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1. Association between combination antibiotic therapy as opposed as monotherapy and outcomes of ICU patients with Pseudomonas aeruginosa ventilator-associated pneumonia: an ancillary study of the iDIAPASON trial

Author: Arnaud Foucrier, Thomas Dessalle, Sophie Tuffet, Laura Federici, Claire Dahyot‑Fizelier, François Barbier, Julien Pottecher, Antoine Monsel, Tarik Hissem, Jean‑Yves Lefrant, Alexandre Demoule, Jean‑Michel Constantin, Alexandra Rousseau, Tabassome Simon, Marc Leone, Adrien Bouglé, and iDIAPASON Trial Investigators
Subjects: Ventilator-associated pneumonia, Pseudomonas aeruginosa, Antibiotic therapy, Combination therapy, Medical emergencies. Critical care. Intensive care. First aid, RC86-88.9
Abstract: Abstract Background The optimal treatment duration and the nature of regimen of antibiotics (monotherapy or combination therapy) for Pseudomonas aeruginosa ventilator‑associated pneumonia (PA-VAP) remain debated. The aim of this study was to evaluate whether a combination antibiotic therapy is superior to a monotherapy in patients with PA-VAP in terms of reduction in recurrence and death, based on the 186 patients included in the iDIAPASON trial, a multicenter, randomized controlled trial comparing 8 versus 15 days of antibiotic therapy for PA-VAP. Methods Patients with PA-VAP randomized in the iDIAPASON trial (short-duration—8 days vs. long-duration—15 days) and who received appropriate antibiotic therapy were eligible in the present study. The main objective is to compare mortality at day 90 according to the antibiotic therapy received by the patient: monotherapy versus combination therapy. The primary outcome was the mortality rate at day 90. The primary outcome was compared between groups using a Chi-square test. Time from appropriate antibiotic therapy to death in ICU or to censure at day 90 was represented using Kaplan–Meier survival curves and compared between groups using a Log-rank test. Results A total of 169 patients were included in the analysis. The median duration of appropriate antibiotic therapy was 14 days. At day 90, among 37 patients (21.9%) who died, 17 received monotherapy and 20 received a combination therapy (P = 0.180). Monotherapy and combination antibiotic therapy were similar for the recurrence rate of VAP, the number of extra pulmonary infections, or the acquisition of multidrug-resistant (MDR) bacteria during the ICU stay. Patients in combination therapy were exposed to mechanical ventilation for 28 ± 12 days, as compared with 23 ± 11 days for those receiving monotherapy (P = 0.0243). Results remain similar after adjustment for randomization arm of iDIAPASON trial and SOFA score at ICU admission. Conclusions Except longer durations of antibiotic therapy and mechanical ventilation, potentially related to increased difficulty in achieving clinical cure, the patients in the combination therapy group had similar outcomes to those in the monotherapy group. Trial registration: NCT02634411 , Registered 15 December 2015.
Published: 2023
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2. Use of the OpinionFamily program to improve satisfaction among families of intensive care unit patients

Author: Vincent Labbé, Elise Morawiec, Naïke Bigé, Irma Bourgeon-Ghittori, Keyvan Razazi, Armand Mekontso Dessap, Sophie Tuffet, Alexandra Rousseau, Muriel Fartoukh, and the OpinionFamily Group
Subjects: Medical emergencies. Critical care. Intensive care. First aid, RC86-88.9
Published: 2023
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3. Circulating microvesicles correlate with radiation proctitis complication after radiotherapy

Author: Alexandre Ribault, Mohamed Amine Benadjaoud, Claire Squiban, Laurent Arnaud, Coralie Judicone, Aurélie S. Leroyer, Alexandra Rousseau, Christelle Huet, Chandan Guha, Marc Benderitter, Romaric Lacroix, Stephane Flamant, Emily I. Chen, Jean-Marc Simon, and Radia Tamarat
Subjects: Medicine, Science
Abstract: Abstract In a large retrospective study, we assessed the putative use of circulating microvesicles (MVs), as innovative biomarkers of radiation toxicity in a cohort of 208 patients with prostate adenocarcinoma overexposed to radiation. The level of platelet (P)-, monocyte (M)- and endothelial (E)-derived MVs were assessed by flow cytometry. Rectal bleeding toxicity scores were collected at the time of blood sampling and during the routine follow-up and were tested for association with MVs using a multivariate logistic regression. MVs dosimetric correlation was investigated using dose volume histograms information available for a subset of 36 patients. The number of PMVs was significantly increased in patients with highest toxicity grades compared to lower grades. Risk prediction analysis revealed that increased numbers of PMVs, and an increased amount of MMVs relative to EMVs, were associated with worst rectal bleeding grade compared to the time of blood sampling. Moreover, a significant correlation was found between PMV and MMV numbers, with the range of doses up to the median exposure (40 Gy) of bladder/rectum and anterior rectal wall, respectively. MVs could be considered as new biomarkers to improve the identification of patients with high toxicity grade and may be instrumental for the prognosis of radiation therapy complications.
Published: 2023
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4. Impact of COVID-19 lockdown on maternal psychological status, the couple’s relationship and mother-child interaction: a prospective study

Author: Sylvie Viaux-Savelon, Paul Maurice, Alexandra Rousseau, Chloe Leclere, Manon Renout, Laura Berlingo, David Cohen, and Jean-Marie Jouannic
Subjects: Covid-19, Pregnancy, Lockdown, Depression, Anxiety, Post-traumatic stress, Gynecology and obstetrics, RG1-991
Abstract: Abstract Background To compare the rate of postpartum depression (PPD) during the first COVID-19 lockdown with the rate observed prior to the pandemic, and to examine factors associated with PPD. Methods This was a prospective study. Women who gave birth during the first COVID-19 lockdown (spring 2020) were offered call-interviews at 10 days and 6–8 weeks postpartum to assess PPD using the Edinburgh Postnatal Depression Scale (EPDS). Post-traumatic symptoms (Perinatal Post-traumatic Stress Disorder Questionnaire, PPQ), couple adjustment, and interaction and mother-to-infant bonding were also evaluated. The observed PPD rate was compared to the one reported before the pandemic. Factors associated with an increased risk of PPD were studied. The main outcome measures were comparison of the observed PPD rate (EPDS score > 12) to pre-pandemic rate. Results Of the 164 women included, 27 (16.5% [95%CI: 11.14–23.04]) presented an EPDS score > 12 either at 10 days or 6–8 weeks postpartum. This rate was similar to the one of 15% reported prior to the pandemic (p = 0.6). Combined EPDS> 12 or PPQ > 6 scores were observed in 20.7% of the mothers [95%CI: 14.8–0.28]. Maternal hypertension/preeclampsia (p = 0.007), emergency cesarean section (p = 0.03), and neonatal complications (p = 0.008) were significantly associated with an EPDS> 12 both in univariate and multivariate analysis (OR = 10 [95%CI: 1.5–68.7], OR = 4.09[95%CI: 1.2–14], OR = 4.02[95%CI: 1.4–11.6], respectively). Conclusions The rate of major PPD in our population did not increase during the first lockdown period. However, 20.7% of the women presented with post-traumatic/depressive symptoms. Trial registration NCT04366817.
Published: 2022
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5. AI-based chatbot micro-intervention for parents: Meaningful engagement, learning, and efficacy

Author: Guido A. Entenberg, Sophie Mizrahi, Hilary Walker, Shirin Aghakhani, Karin Mostovoy, Nicole Carre, Zendrea Marshall, Gilly Dosovitsky, Daniellee Benfica, Alexandra Rousseau, Grace Lin, and Eduardo L. Bunge
Subjects: chatbot, parenting, artificial intelligence, learning, efficacy, intervention, Psychiatry, RC435-571
Abstract: IntroductionMental health issues have been on the rise among children and adolescents, and digital parenting programs have shown promising outcomes. However, there is limited research on the potential efficacy of utilizing chatbots to promote parental skills. This study aimed to understand whether parents learn from a parenting chatbot micro intervention, to assess the overall efficacy of the intervention, and to explore the user characteristics of the participants, including parental busyness, assumptions about parenting, and qualitative engagement with the chatbot.MethodsA sample of 170 parents with at least one child between 2–11 years old were recruited. A randomized control trial was conducted. Participants in the experimental group accessed a 15-min intervention that taught how to utilize positive attention and praise to promote positive behaviors in their children, while the control group remained on a waiting list.ResultsResults showed that participants engaged with a brief AI-based chatbot intervention and were able to learn effective praising skills. Although scores moved in the expected direction, there were no significant differences by condition in the praising knowledge reported by parents, perceived changes in disruptive behaviors, or parenting self-efficacy, from pre-intervention to 24-hour follow-up.DiscussionThe results provided insight to understand how parents engaged with the chatbot and suggests that, in general, brief, self-guided, digital interventions can promote learning in parents. It is possible that a higher dose of intervention may be needed to obtain a therapeutic change in parents. Further research implications on chatbots for parenting skills are discussed.
Published: 2023
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6. Immunogenicity and reactogenicity of heterologous and homologous mRNA-1273 and BNT162b2 vaccination: A multicenter non-inferiority randomized trial

Author: Cécile Janssen, Marine Cachanado, Laetitia Ninove, Marie Lachatre, Jocelyn Michon, Olivier Epaulard, Zoha Maakaroun-Vermesse, Christian Chidiac, Bruno Laviolle, Hugues Aumaitre, Ady Assaf, Karine Lacombe, Catherine Schmidt-Mutter, Elisabeth Botelho-Nevers, Magali Briere, Thomas Boisson, Paul Loubet, Boris Bienvenu, Olivier Bouchaud, Amel Touati, Christine Pereira, Alexandra Rousseau, Laurence Berard, Melissa Montil, Xavier de Lamballerie, Tabassome Simon, and Odile Launay
Subjects: Medicine (General), R5-920
Abstract: Summary: Background: Although effective mRNA vaccines for SARS-CoV-2 infection have been deployed worldwide, their interchangeability could facilitate the scale-up of vaccination programs. The objective of the trial was to assess whether the immune response induced by a heterologous SARS-CoV-2 mRNA primo vaccination is non-inferior to that of a homologous mRNA vaccination. Methods: We conducted a multicenter, randomized, open-label trial in adults 18 years of age and older who received a first dose of SARS-CoV-2 mRNA vaccine. Participants were randomly assigned in a 1:1 ratio to receive a second dose of BNT162b2 or mRNA-1273, 28 to 49 days after the first dose. Randomization was stratified on the vaccine received at the first vaccination. The primary endpoint was the anti-spike IgG antibodies titer measured 28 days after the second vaccine dose. This study is registered with ClinicalTrials.gov, Trial, NCT04900467. Findings: Of the 414 randomized participants recruited from May 28 to July 2, 2021, 390 were included in the per protocol analysis: 94 participants in group 1 (BNT162b2/BNT162b2), 96 in group 2 (BNT162b2/mRNA-1273), 97 in group 3 (mRNA-1273/mRNA-1273), and 103 in group 4 (mRNA-1273/BNT162b2). The geometric mean titers ratios of anti-spike IgG antibodies for each heterologous regimen relative to the corresponding homologous regimen were 1·37 (two-sided 95% CI, 1·10 to 1·72) in the groups 1 and 2 and 0·67 (two-sided 95% CI, 0·55 to 0·82) in the groups 3 and 4. Levels of neutralizing antibodies to the main circulating SARS-Cov-2 viral strains were higher with the vaccine regimen containing mRNA-1273. Participants who received mRNA-1273 as a second dose experienced a higher rate of local adverse reactions and general symptoms than those who received BNT162b2 (p
Published: 2022
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7. Efficacy of a nurse-led patient education intervention in promoting safety skills of patients with inflammatory arthritis treated with biologics: a multicentre randomised clinical trial

Author: Laure Gossec, Sophie Pouplin, Catherine Beauvais, Christelle Sordet, Yves Maugars, Aleth Perdriger, Françoise Fayet, Alexandra Rousseau, Carine Savel, Sophie Tuffet, Rose Marie Poilverd, Véronique Ségard, Béatrice Godon, Christian L’amour, Fabienne Brin, Patricia Peyrard, Fabienne Chalier, Béatrice Pallot-Prades, and Isabelle Griffoul
Subjects: Medicine
Published: 2022
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8. Transcutaneous vagus nerve stimulation in erosive hand osteoarthritis: protocol for the randomised, double-blind, sham-controlled ESTIVAL trial

Author: Francis Berenbaum, Julien Champey, Jérémie Sellam, Annick Tibi, Emmanuel Maheu, Pascal Richette, Grégoire Cormier, Jacques-Eric Gottenberg, Hubert Marotte, Alain Saraux, Sylvain Mathieu, Tabassome Simon, Jean-Philippe Bastard, Soraya Fellahi, Alexandra Rousseau, Laurence Bérard, François Rannou, Sandra Desouches, Yves-Marie Pers, Eric Lespessailles, Daniel Wendling, florent Eymard, Paul Ornetti, Denis Arniaud, Anne-Christine Rat, Nicolas Poursac, Roland Chapurlat, Anne Miquel, Alice Courties, Camille Deprouw, Amel Touati, Johanna Kalsch, Margaux Villevieille, Yves Henrontin, and Christian H. Roux
Subjects: Medicine
Abstract: Introduction Patients with erosive hand osteoarthritis (EHOA) experience pain and inflammation, two features that can be targeted by vagus nerve stimulation using electrical auricular transcutaneous vagus nerve stimulation (tVNS). A pilot study demonstrated the feasibility of the procedure, so we designed a randomised sham-controlled trial to determine the safety and efficacy of tVNS in EHOA.Methods and analysis ESTIVAL Study (Essai randomisé comparant la STImulation auriculaire transcutanée du nerf Vague versus sham stimulation dans l’Arthrose DigitaLe Érosive symptomatique et inflammatoire) is a superiority, randomised, double-blind sham-controlled trial comparing two parallel arms: active and sham tVNSs in a 1:1 ratio. Patients with symptomatic EHOA (score ≥40/100 mm on a visual analogue scale (VAS) for pain of 0–100 mm) and inflammatory EHOA (≥1 clinical and ultrasonography-determined interphalangeal synovitis) are included in 18 hospital centres (17 rheumatology and 1 rehabilitation departments) in France. Active and sham tVNSs use an auricular electrode connected to the Vagustim device, with no electric current delivered in the sham group. Patients undergo stimulation for 20 min/day for 12 weeks. The follow-up visits take place at weeks 4, 8 and 12. The enrolment duration is 2 years and started in April 2021; 156 patients are scheduled to be included. The primary outcome is the difference in self-reported hand pain in the previous 48 hours measured on a VAS of 0–100 mm between baseline and week 12. Secondary outcomes include other pain outcomes, function, quality of life, serum biomarker levels, compliance and tolerance. For a subset of patients, MRI of the hand is performed at baseline and week 12 to compare the change in Outcome Measures in Rheumatology/Hand Osteoarthritis MRI Scoring System subscores. The primary analysis will be performed at the end of the study according to the intent-to-treat principle.Ethics and dissemination Ethics approval was obtained from the institutional review board (Comité de Protection des Personnes, 2020-A02213-36). All participants will be required to provide written informed consent. The findings will be published in peer-reviewed journals.Trial registration number NCT04520516; Pre-results.Protocol version and number V.2 of 11 March 2021.
Published: 2022
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9. Fecal microbiota transplantation to maintain remission in Crohn’s disease: a pilot randomized controlled study

Author: Harry Sokol, Cecilia Landman, Philippe Seksik, Laurence Berard, Mélissa Montil, Isabelle Nion-Larmurier, Anne Bourrier, Guillaume Le Gall, Valérie Lalande, Alexis De Rougemont, Julien Kirchgesner, Anne Daguenel, Marine Cachanado, Alexandra Rousseau, Élodie Drouet, Michelle Rosenzwajg, Hervé Hagege, Xavier Dray, David Klatzman, Philippe Marteau, Saint-Antoine IBD Network, Laurent Beaugerie, and Tabassome Simon
Subjects: Fecal microbiota transplantation, Crohn’s disease, Randomized controlled trial, Microbial ecology, QR100-130
Abstract: Abstract Background The role of the gut microbiota in Crohn’s disease (CD) is established and fecal microbiota transplantation (FMT) is an attractive therapeutic strategy. No randomized controlled clinical trial results are available. We performed a randomized, single-blind, sham-controlled pilot trial of FMT in adults with colonic or ileo-colonic CD. Method Patients enrolled while in flare received oral corticosteroid. Once in clinical remission, patients were randomized to receive either FMT or sham transplantation during a colonoscopy. Corticosteroids were tapered and a second colonoscopy was performed at week 6. The primary endpoint was the implantation of the donor microbiota at week 6 (Sorensen index > 0.6). Results Eight patients received FMT and nine sham transplantation. None of the patients reached the primary endpoint. The steroid-free clinical remission rate at 10 and 24 weeks was 44.4% (4/9) and 33.3% (3/9) in the sham transplantation group and 87.5% (7/8) and 50.0% (4/8; one patient loss of follow-up while in remission at week 12 and considered in flare at week 24) in the FMT group. Crohn’s Disease Endoscopic Index of Severity decreased 6 weeks after FMT (p = 0.03) but not after sham transplantation (p = 0.8). Conversely, the CRP level increased 6 weeks after sham transplantation (p = 0.008) but not after FMT (p = 0.5). Absence of donor microbiota engraftment was associated with flare. No safety signal was identified. Conclusion The primary endpoint was not reached for any patient. In this pilot study, higher colonization by donor microbiota was associated with maintenance of remission. These results must be confirmed in larger studies (NCT02097797). Video abstract.
Published: 2020
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10. Combined use of a broad-panel respiratory multiplex PCR and procalcitonin to reduce duration of antibiotics exposure in patients with severe community-acquired pneumonia (MULTI-CAP): a multicentre, parallel-group, open-label, individual randomised trial conducted in French intensive care units

Author: Isabelle Durand-Zaleski, Eric Maury, Bruno Megarbane, Tabassome Simon, Jean-François Timsit, Jean Dellamonica, Saad Nseir, Alexandra Rousseau, Laurence Bérard, Kada Klouche, Yacine Tandjaoui-Lambiotte, Jean Reignier, Laurent Argaud, Muriel Fartoukh, Keyvan Razazi, Laurence Armand-Lefevre, Bertrand Souweine, Guillaume Voiriot, Charlotte Verdet, Juliette Patrier, Jean-Christophe Richard, Carole Schwebel, Jean-Christophe Navellou, Pierre-Francois Dequin, Pierre-Edouard Bollaert, Marc Gainnier, and Julien Bohe
Subjects: Medicine
Abstract: Introduction At the time of the worrying emergence and spread of bacterial resistance, reducing the selection pressure by reducing the exposure to antibiotics in patients with community-acquired pneumonia (CAP) is a public health issue. In this context, the combined use of molecular tests and biomarkers for guiding antibiotics discontinuation is attractive. Therefore, we have designed a trial comparing an integrated approach of diagnosis and treatment of severe CAP to usual care.Methods and analysis The multiplex PCR and procalcitonin to reduce duration of antibiotics exposure in patients with severe-CAP (MULTI-CAP) trial is a multicentre (n=20), parallel-group, superiority, open-label, randomised trial. Patients are included if adult admitted to intensive care unit for a CAP. Diagnosis of pneumonia is based on clinical criteria and a newly appeared parenchymal infiltrate. Immunocompromised patients are excluded. Subjects are randomised (1:1 ratio) to either the intervention arm (experimental strategy) or the control arm (usual strategy). In the intervention arm, the microbiological diagnosis combines a respiratory multiplex PCR (mPCR) and conventional microbiological investigations. An algorithm of early antibiotic de-escalation or discontinuation is recommended, based on mPCR results and the procalcitonin value. In the control arm, only conventional microbiological investigations are performed and antibiotics de-escalation remains at the clinician’s discretion. The primary endpoint is the number of days alive without any antibiotic from the randomisation to day 28. Based on our hypothesis of 2 days gain in the intervention arm, we aim to enrol a total of 450 patients over a 30-month period.Ethics and dissemination The MULTI-CAP trial is conducted according to the principles of the Declaration of Helsinki, is registered in Clinical Trials and has been approved by the Committee for Protection of Persons and the National French Drug Safety Agency. Written informed consents are obtained from all the patients (or representatives). The results will be disseminated through educational institutions, submitted to peer-reviewed journals for publication and presented at medical congresses.Trial registration number NCT03452826; Pre-results.
Published: 2021
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11. Effectiveness and costs of non-invasive foetal RHD genotyping in rhesus-D negative mothers: a French multicentric two-arm study of 850 women

Author: Meryl Darlington, Bruno Carbonne, Agnès Mailloux, Yves Brossard, Annie Levy-Mozziconacci, Anne Cortey, Hassani Maoulida, Tabassome Simon, Alexandra Rousseau, Isabelle Durand-Zaleski, and the GENIFERH1 Study Group
Subjects: Anti-D immunoglobulin, Non-invasive foetal RHD genotyping, Cost evaluation, Cost-effectiveness, Gynecology and obstetrics, RG1-991
Abstract: Abstract Background The determination of foetal Rhesus D (RHD) status allows appropriate use of IgRh prophylaxis by restricting its use to cases of RHD feto-maternal incompatibilities. There is a degree of uncertainty about the cost-effectiveness of foetal RHD determination, yet screening programs are being introduced into clinical practice in many countries. This paper evaluates the impact of non-invasive foetal Rhesus D (RHD) status determination on the costs of managing RHD-negative pregnant women and on the appropriate use of anti-D prophylaxis in a large sample of RHD-negative pregnant women using individual prospectively collected clinical and economic data. Methods A prospective two-armed trial of RHD negative pregnant women was performed in 11 French Obstetric Departments. Non-invasive foetal RHD genotyping was performed before 26 weeks' gestation in the experimental arm whereas the control arm participants received usual care. The costs associated with patient management in relation to their RHD negative status (biological tests, anti-D prophylaxis and visits) were calculated from inclusion to the end of the postpartum period. The costs of hospital admissions during pregnancy and delivery were also determined. Results A total of 949 patients were included by 11 centres between 2009 and 2012, and 850 completed follow-up, including medical and biological monitoring. Patients were separated into two groups: the genotyping group (n=515) and the control group (n=335). The cost of the genotyping was estimated at 140 euros per test. The total mean cost per patient was estimated at €3,259 (SD ± 1,120) and €3,004 (SD ± 1,004) in the genotyping and control groups respectively. The cost of delivery represented three quarters of the total cost in both groups. The performance of managing appropriately RHD negative anti-D prophylaxis was 88% in the genotyping group, versus 65% in the control group. Using the costs related to RHD status (biological tests, anti-D immunoglobulin injections and visits) the incremental cost-effectiveness ratio (ICER) was calculated to be €578 for each percentage gain in women receiving appropriate management. Conclusion Early knowledge of the RHD status of the foetus using non-invasive foetal RHD genotyping significantly improved the management of RHD negative pregnancies with a small increase in cost. Trial registration Clinical trials registry-NCT00832962–13 January 2009 - retrospectively registered.
Published: 2018
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12. Randomised trial of first-line bronchial artery embolisation for non-severe haemoptysis of mild abundance

Author: Benjamin Planquette, Vincent Labbe, Tabassome Simon, Alexandra Rousseau, Jacques Cadranel, Antoine Khalil, Emmanuel Bergot, Gérard Zalcman, Guy Meyer, Philippe Cluzel, Vincent Jounieaux, Alexandre Demoule, Muriel Fartoukh, Aude Gibelin, Olivier Sanchez, THOMAS SIMILOWSKI, Claire Andrejak, Valérie Chabbert, Michel Djibré, Sophie Tuffet, Cendrine Godet, Sandrine Pontier-Marchandise, Julien Mayaux, Marc Sapoval, Vincent Le Pennec, Marie-France Carette, Clarisse Blayau, Guillaume Voiriot, Alexandre Duguet, Hélène Prodanovik, Guillaume Briend, Anne Roche, Costantino Del Giudice, Olivier Pellerin, Marie-Pierre Revel, Patrick Courtheoux, Jean Claude Meurice, Elise Antone, and Alexandre Remond
Subjects: Medicine, Diseases of the respiratory system, RC705-779
Abstract: Background Whereas first-line bronchial artery embolisation (BAE) is considered standard of care for the management of severe haemoptysis, it is unknown whether this approach is warranted for non-severe haemoptysis.Research question To assess the efficacy on bleeding control and the safety of first-line BAE in non-severe haemoptysis of mild abundance.Study design and methods This multicentre, randomised controlled open-label trial enrolled adult patients without major comorbid condition and having mild haemoptysis (onset
Published: 2021
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13. Maintenance Therapy With Interleukin-2 for Childhood AML

Author: Arnaud Petit, Stéphane Ducassou, Thierry Leblanc, Marlène Pasquet, Alexandra Rousseau, Christine Ragu, Marine Cachanado, Brigitte Nelken, Yves Bertrand, Gérard Michel, Virginie Gandemer, Wendy Cuccuini, Odile Fenneteau, Hélène Lapillonne, Anne Auvrignon, André Baruchel, Guy Leverger, and on behalf of SFCE
Subjects: Diseases of the blood and blood-forming organs, RC633-647.5
Abstract: Abstract. Despite significant progress in the treatment of pediatric acute myeloblastic leukemia (AML), relapse remains the commonest cause of death. Randomized ELAM02 trial questioned if maintenance therapy with interleukin-2 (IL2), for 1 year, improves disease-free survival (DFS). Patients aged 0 to 18 years, with newly diagnosed AML (excluding patients with acute promyelocytic leukemia or down syndrome AML) were enrolled. They received 1 course of induction treatment (cytarabine and mitoxantrone) and 3 courses of consolidation treatment (high-dose cytarabine in courses 1 and 3). According to the cytogenetics risk, patients not undergoing hematopoietic stem cell transplantation, still in complete remission (CR) after the third course of consolidation treatment, were eligible for randomization to 1 year of maintenance therapy with monthly courses of IL2 or no maintenance treatment. There were 438 evaluable patients, 154 of whom were randomized to the IL2/no maintenance groups. Relapse occurred in 28 patients from the IL2+ group and 29 patients in the IL2− group. Survival was similar in the 2 groups, with a 4-year DFS of 62% without IL2 and 66% with IL2 (P = 0.75). In the CBF population, 4-year DFS was 55% without IL2 and 78% with IL2 (P = 0.07). No deaths from toxicity or excess of serious adverse events related to IL2 treatment were recorded. Prolonged IL2 for maintenance therapy after intensive chemotherapy is feasible and safe in pediatric AML patients in their first CR. Such treatment did not improve DFS in this study, but a positive trend was observed in favor of IL2 maintenance therapy among core binding factor acute myeloblastic leukemia.
Published: 2018
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14. Molecular Profiling Defines Distinct Prognostic Subgroups in Childhood AML: A Report From the French ELAM02 Study Group

Author: Alice Marceau-Renaut, Nicolas Duployez, Benoît Ducourneau, Myriam Labopin, Arnaud Petit, Alexandra Rousseau, Sandrine Geffroy, Maxime Bucci, Wendy Cuccuini, Odile Fenneteau, Philippe Ruminy, Brigitte Nelken, Stéphane Ducassou, Virginie Gandemer, Thierry Leblanc, Gérard Michel, Yves Bertrand, André Baruchel, Guy Leverger, Claude Preudhomme, and Hélène Lapillonne
Subjects: Diseases of the blood and blood-forming organs, RC633-647.5
Abstract: Abstract. Despite major treatment improvements over the past decades, pediatric acute myeloid leukemia (AML) is still a life-threatening malignancy with relapse rates up to 30% and survival rates below 75%. A better description of the pattern of molecular aberrations in childhood AML is needed to refine prognostication in such patients. We report here the comprehensive molecular landscape using both high-throughput sequencing focused on 36 genes and ligation-dependent RT-PCR in 385 children with de novo AML enrolled in the prospective ELAM02 trial and we evaluated their prognostic significance. Seventy-six percent of patients had at least 1 mutation among the genes we screened. The most common class of mutations involved genes that control kinase signaling (61%) followed by transcription factors (16%), tumor suppressors (14%), chromatin modifiers (9%), DNA methylation controllers (8%), cohesin genes (5%), and spliceosome (3%). Moreover, a recurrent transcript fusion was detected in about a half of pediatric patients. Overall, CBF rearrangements, NPM1 and double CEBPA mutations represented 37% of the cohort and defined a favorable molecular subgroup (3 years OS: 92.1%) while NUP98 fusions, WT1, RUNX1, and PHF6 mutations (15% of the cohort) segregated into a poor molecular subgroup (3 years OS: 46.1%). KMT2A-rearrangements (21% of the cohort) were associated with an intermediate risk. Despite some overlaps, the spectrum of molecular aberrations and their prognostic significance differ between childhood and adult AML. These data have important implications to contribute in refining risk stratification of pediatric AML and show the need for further validations in independent pediatric cohorts.
Published: 2018
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15. Diagnostic value of molecular tests for the management of postoperative pneumonia in thoracic surgery

Author: Matthieu Turpin, Sophie Tuffet, Charlotte Verdet, Julien Lopinto, Michel Djibré, Ludovic Lassel, Juliette Camuset, Sophie Dupeyrat, Medhi Hafiani, Christophe Quesnel, Jalal Assouad, Guillaume Voiriot, Alexandra Rousseau, and Muriel Fartoukh
Subjects: Microbiology (medical), Infectious Diseases
Published: 2023
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16. Efficacy and safety of methylprednisolone pulse followed by oral prednisone vs. oral prednisone alone in sarcoidosis tubulointerstitial nephritis: a randomized, open-label, controlled clinical trial

Author: Matthieu, Mahevas, Vincent, Audard, Alexandra, Rousseau, Alexandre, Cez, Dominique, Guerrot, David, Verhelst, Michel, Delahousse, Catherine, Hanrotel, Evangeline, Pillebout, Eric, Daugas, Evguenia, Krastinova, Dominique, Valeyre, Jean-Jacques, Boffa, CHU Henri Mondor, Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Maladies rénales fréquentes et rares : des mécanismes moléculaires à la médecine personnalisée (CoRaKID), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), CHU Tenon [AP-HP], Endothélium, valvulopathies et insuffisance cardiaque (EnVI), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre hospitalier d'Avignon, Hôpital Foch [Suresnes], Hôpital de la Cavale Blanche - CHRU Brest (CHU - BREST ), Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Centre de recherche sur l'Inflammation (CRI (UMR_S_1149 / ERL_8252 / U1149)), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité)
Subjects: Transplantation, Nephrology, [SDV.MHEP.UN]Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology
Abstract: Background We determine the benefit of pulsed methylprednisolone for improving kidney function in patients with sarcoidosis tubulointerstitial nephritis. Methods We conducted a multicenter, prospective, randomized, open-label, controlled trial in patients with biopsy-proven acute tubulointerstitial nephritis caused by sarcoidosis at 21 sites in France. Patients were randomly assigned to receive a methylprednisolone pulse 15 mg/kg/day for 3 days, then oral prednisone (MP group) or oral prednisone 1 mg/kg/day alone (PRD group). The primary end point was a positive response at 3 months, defined as a doubling of estimated glomerular filtration rate (eGFR) compared with the eGFR before randomization. Results We randomized 40 participants. Baseline eGFR before PRD was 22 mL/min/1.73m2 {interquartile range [IQR], 16–44} and before MP was 25 mL/min/1.73m2 (IQR, 22–36) (P = .3). The two groups did not differ in underlying pathological lesions, including mean percentage of interstitial fibrosis and intensity of interstitial infiltrate. In the intent-to-treat population, the median eGFR at 3 months did not significantly differ between the PRD and MP groups: 45 (IQR, 34–74) and 46 (IQR, 39–65) mL/min/1.73m2. The primary end point at 3 months was achieved in 16 of 20 (80%) PRD patients and 10 of 20 (50%) MP patients (P = .0467). The eGFR was similar between the two groups after 1, 3, 6, and 12 months of treatment. For both groups, eGFR at 1 month was strongly correlated with eGFR at 12 months (P Conclusion Compared with a standard oral steroid regimen, intravenous MP may have no supplemental benefit for renal function in patients with tubulointerstitial nephritis caused by sarcoidosis. Trial Registration: ClinicalTrials.gov: NCT01652417; EudraCT: 2012–000149-11
Published: 2022
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17. Physicians' Attitudes Towards the Advice of a Guideline-Based Decision Support System: A Case Study With OncoDoc2 in the Management of Breast Cancer Patients.

Author: Jacques Bouaud, Jean-Philippe Spano, Jean-Pierre Lefranc, Isabelle Cojean-Zelek, Brigitte Blaszka-Jaulerry, Laurent Zelek, Axel Durieux, Christophe Tournigand, Alexandra Rousseau, Pierre-Yves Vandenbussche, and Brigitte Séroussi
Published: 2015
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18. Indirect H2O2 synthesis without H2

Author: Curtis Berlinguette, Arthur Fink, Roxanna Delima, Alexandra Rousseau, Camden Hunt, Natalie LeSage, Aoxue Huang, and Monika Stolar
Abstract: Industrial hydrogen peroxide (H2O2) is synthesized using carbon-intensive H2 gas production and purification, anthraquinone hydrogenation, and anthrahydroquinone oxidation. Electrochemical hydrogenation (ECH) of anthraquinones offers a carbon-neutral alternative for generating H2O2 using renewable electricity and water instead of H2 gas. However, ECH has not yet had an impact on the industry because H2O2 formation rates are too low for commercialization. We report here that a membrane reactor enabled us to hydrogenate anthraquinone (0.25 molar) with a current efficiency of > 80% at current densities of 75 milliamperes per square centimeter. We also demonstrate continuous H2O2 synthesis from the hydrogenated anthraquinones over the course of 48 hours. This study represents the fastest rates of electrochemical anthraquinone hydrogenation ever reported (1.32 ± 0.14 millimoles per hour normalized per centimeter squared of geometric surface of electrode), and provides a pathway toward carbon-neutral H2O2 synthesis.
Published: 2023
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19. Quels sont les patients atteints d'un cancer du sein dont la décision de prise en charge thérapeutique bénéficie de l'utilisation d'un système d'aide à la décision ? Un exemple utilisant la fouille de données et OncoDoc2.

Author: Jacques Bouaud, Arnaud Soulet, Jean-Philippe Spano, Jean-Pierre Lefranc, Isabelle Cojean-Zelek, Brigitte Blaszka-Jaulerry, Laurent Zelek, Axel Durieux, Christophe Tournigand, Nizar Messai, Alexandra Rousseau, and Brigitte Séroussi
Published: 2014

20. Comparison of 8 versus 15 days of antibiotic therapy for Pseudomonas aeruginosa ventilator-associated pneumonia in adults: a randomized, controlled, open-label trial

Author: Adrien, Bouglé, Sophie, Tuffet, Laura, Federici, Marc, Leone, Antoine, Monsel, Thomas, Dessalle, Julien, Amour, Claire, Dahyot-Fizelier, François, Barbier, Charles-Edouard, Luyt, Olivier, Langeron, Bernard, Cholley, Julien, Pottecher, Tarik, Hissem, Jean-Yves, Lefrant, Benoit, Veber, Matthieu, Legrand, Alexandre, Demoule, Pierre, Kalfon, Jean-Michel, Constantin, Alexandra, Rousseau, Tabassome, Simon, Arnaud, Foucrier, Nora, Soussi, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Sorbonne Université (SU), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Hospitalier Sud Francilien, Service Anesthésie et Réanimation [Hôpital Nord - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], Immunologie - Immunopathologie - Immunothérapie [CHU Pitié Salpêtrière] (I3), CHU Charles Foix [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Centre d'investigation clinique Biothérapie [CHU Pitié-Salpêtrière] (CIC-BTi), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Pharmacologie des anti-infectieux et antibiorésistance (PHAR2), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Poitiers - Faculté de Médecine et de Pharmacie, Université de Poitiers, Centre hospitalier universitaire de Poitiers (CHU Poitiers), Centre Hospitalier Régional d'Orléans (CHRO), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Université de Strasbourg (UNISTRA), CHU Strasbourg, Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Initial MAnagement and prevention of acute orGan failures IN critically ill patiEnts (IMAGINE), Université de Montpellier (UM), CHU Rouen, Normandie Université (NU), Hôpital Lariboisière-Fernand-Widal [APHP], Hôpital Louis Pasteur [Chartres], CHU Clermont-Ferrand, Centre de Ressources Biologiques APHP-SU (PASS-CRB-APHP-SU), Unité Mixte de Service Production et Analyse de données en Sciences de la vie et en Santé (PASS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), and Hôpital Beaujon [AP-HP]
Subjects: Adult, MESH: Humans, Survival, Pneumonia, Ventilator-Associated, MESH: Adult, MESH: Pneumonia, Ventilator-Associated, Antibiotic therapy, Critical Care and Intensive Care Medicine, Respiration, Artificial, Anti-Bacterial Agents, Ventilator-associated pneumonia, Intensive Care Units, Recurrence, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, MESH: Anti-Bacterial Agents, MESH: Intensive Cate Units, MESH: Pseudomonas aeruginosa, Pseudomonas aeruginosa, Humans, MESH: Respiration, Artificial
Abstract: International audience; Purpose: Duration of antibiotic therapy for ventilator-associated pneumonia (VAP) due to non-fermenting Gram-negative bacilli (NF-GNB), including Pseudomonas aeruginosa (PA) remains uncertain. We aimed to assess the non-inferiority of a short duration of antibiotics (8 days) vs. prolonged antibiotic therapy (15 days) in VAP due to PA (PA-VAP).Methods: We conducted a nationwide, randomized, open-labeled, multicenter, non-inferiority trial to evaluate optimal duration of antibiotic treatment in PA-VAP. Eligible patients were adults with diagnosis of PA-VAP and randomly assigned in 1:1 ratio to receive a short-duration treatment (8 days) or a long-duration treatment (15 days). A pre-specified analysis was used to assess a composite endpoint combining mortality and PA-VAP recurrence rate during hospitalization in the intensive care unit (ICU) within 90 days.Results: The study was stopped after 24 months due to slow inclusion rate. In intention-to-treat population (n = 186), the percentage of patients who reached the composite endpoint was 25.5% (N = 25/98) in the 15-day group versus 35.2% (N = 31/88) in the 8-day group (difference 9.7%, 90% confidence interval (CI) -1.9%-21.2%). The percentage of recurrence of PA-VAP during the ICU stay was 9.2% in the 15-day group versus 17% in the 8-day group. The two groups had similar median days of mechanical ventilation, of ICU stay, number of extra pulmonary infections and acquisition of multidrug-resistant (MDR) pathogens during ICU stay.Conclusions: Our study failed to show the non-inferiority of a short duration of antibiotics in the treatment of PA-VAP, compared to a long duration. The short duration strategy may be associated to an increase of PA-VAP recurrence. However, the lack of power limits the interpretation of this study.
Published: 2022
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21. DIGICOD, cohorte prospective observationnelle hospitalière de patients souffrant d’arthrose digitale : méthodologie et caractéristiques de la population d’inclusion

Author: Jérémie Sellam, Emmanuel Maheu, Michel D. Crema, Amel Touati, Alice Courties, Sophie Tuffet, Alexandra Rousseau, Xavier Chevalier, Bernard Combe, Maxime Dougados, Bruno Fautrel, Margreet Kloppenburg, Jean-Denis Laredo, Damien Loeuille, Anne Miquel, François Rannou, Pascal Richette, Tabassome Simon, and Francis Berenbaum
Subjects: Rheumatology
Published: 2022
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22. Impact of carpal tunnel syndrome on symptoms and structural severity of hand osteoarthritis: results from the DIGICOD cohort

Author: Hontongnon Julien Djossou, Sophie Tuffet, Alexandra Rousseau, Augustin Latourte, Jean-Denis Laredo, Francis Berenbaum, Jérémie Sellam, Gestionnaire, HAL Sorbonne Université 5, Service de rhumatologie [CHU Saint-Antoine], CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Société IMAGENE, Centre de Recherche Saint-Antoine (CRSA), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Service de Pharmacologie médicale = service de pharmacologie - Dosage de médicaments [CHU Saint-Antoine], Biologie de l'Os et du Cartilage : Régulations et Ciblages Thérapeutiques (BIOSCAR (UMR_S_1132 / U1132)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Service de Rhumatologie [CHU Lariboisière], Hôpital Lariboisière-Fernand-Widal [APHP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)
Subjects: Cohort Studies, [SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Rheumatology, Osteoarthritis, Humans, General Medicine, Hand, Carpal Tunnel Syndrome, ComputingMilieux_MISCELLANEOUS
Abstract: International audience
Published: 2022
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23. Cyclophosphamide added to glucocorticoids in acute exacerbation of idiopathic pulmonary fibrosis (EXAFIP): a randomised, double-blind, placebo-controlled, phase 3 trial

Author: Abdellatif Tazi, Aurélie Le Borgne-Krams, Marine Cachanado, Tabassome Simon, Sylvain Marchand-Adam, Morgane Didier, Lidwine Wemeau-Stervinou, Sandrine Hirschi, Frédéric Rivière, Arnaud Bourdin, François Lebargy, Stéphane Dominique, Aude Gibelin, Alexandre Chabrol, Tristan Dégot, Jacques Cadranel, Martine Reynaud-Gaubert, Marie-Pierre Debray, Sylvie Leroy, Frédéric Gagnadoux, Emmanuel Bergot, François-Xavier Blanc, Alexandra Rousseau, Raphael Borie, Pierre Yves Brillet, Guillaume Beltramo, Mallorie Kerjouan, Hilario Nunes, Olivia Freynet, Julie Traclet, Bruno Crestani, Anne-Sophie Gamez, Grégoire Prévot, Jean Pastré, Dominique Israel-Biet, Marie-Christine Dombret, Laurent Plantier, Cécile Chenivesse, Laurence Berard, Ana Nieves, Emmanuel Gomez, Dominique Valeyre, Stéphane Jouneau, Anne Gondouin, Elodie Blanchard, C. Launois, Nathalie Bautin, Jean-Marc Naccache, Vincent Cottin, Antoine Parrot, Philippe Bonniaud, Centre de référence maladies rares des maladies pulmonaires rares de l’adulte (CHU Dijon) (CRMR des maladies pulmonaires rares de l’adulte), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Sorbonne Université (SU), Centre hospitalier Saint-Joseph [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Foch [Suresnes], CHU Pontchaillou [Rennes], École des Hautes Études en Santé Publique [EHESP] (EHESP), Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Hôpital Avicenne [AP-HP], Laboratoire d'Excellence INFLAMEX [Paris], Université Sorbonne Paris Cité (USPC), CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), AP-HP - Hôpital Bichat - Claude Bernard [Paris], CHU Saint-Antoine [AP-HP], Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre régional de pharmacovigilance de Marseille Provence Corse [CHU de Marseille] (CRPV-Marseille), Assistance Publique - Hôpitaux de Marseille (APHM)-CHU Marseille, CHU Dijon, Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Les Hôpitaux Universitaires de Strasbourg (HUS), Nouvel Hôpital Civil de Strasbourg, Centre Hospitalier Universitaire de Reims (CHU Reims), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), CHU Lille, Hôpital Albert Calmette, Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre de Référence des Maladies Pulmonaires Rares [Hôpital Louis Pradel - HCL], Hôpital Louis Pradel [CHU - HCL], Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Hospices Civils de Lyon (HCL), Université de Lyon, CIC CHU Lyon (inserm), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Université Côte d'Azur (UCA), Centre Hospitalier Universitaire de Nice (CHU Nice), Université d'Angers (UA), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Hôpital d'instruction des Armées Percy, Service de Santé des Armées, Hôpital Côte de Nacre [CHU Caen], CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Hôpital JeanMinjoz, CHU Bordeaux [Bordeaux], Hôpital Haut-Lévêque [CHU Bordeaux], unité de recherche de l'institut du thorax UMR1087 UMR6291 (ITX), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Nantes Université - UFR de Médecine et des Techniques Médicales (Nantes Univ - UFR MEDECINE), Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ), Centre hospitalier universitaire de Nantes (CHU Nantes), CHU Rouen, Normandie Université (NU), CHU Tenon [AP-HP], Immunologie humaine, physiopathologie & immunothérapie (HIPI (UMR_S_976 / U976)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Institut de Recherche Saint-Louis - Hématologie Immunologie Oncologie (Département de recherche de l’UFR de médecine, ex- Institut Universitaire Hématologie-IUH) (IRSL), Université Paris Cité (UPCité), Physiopathologie et Epidémiologie des Maladies Respiratoires (PHERE (UMR_S_1152 / U1152)), CHU Montpellier, Université de Lille, Institut Pasteur de Lille, Réseau International des Instituts Pasteur (RIIP), Centre d’Infection et d’Immunité de Lille - INSERM U 1019 - UMR 9017 - UMR 8204 (CIIL), Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Centre National de la Recherche Scientifique (CNRS), Roche, Ministere de la Sante et des Solidarites, Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )-Institut National de la Santé et de la Recherche Médicale (INSERM)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université d'Angers (UA), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), CHU Marseille-Assistance Publique-Hôpitaux de Marseille (AP-HM), Hôpital Larrey [Toulouse], CHU Toulouse [Toulouse], Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP), Université de Paris (UP), Centre National de la Recherche Scientifique (CNRS)-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Université de Lille-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Pasteur de Lille, Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP), Université d'Angers (UA)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), and Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)
Subjects: Pulmonary and Respiratory Medicine, medicine.medical_specialty, education.field_of_study, Exacerbation, Cyclophosphamide, business.industry, [SDV]Life Sciences [q-bio], Population, medicine.disease, Placebo, 3. Good health, 03 medical and health sciences, Idiopathic pulmonary fibrosis, 0302 clinical medicine, 030228 respiratory system, Methylprednisolone, Internal medicine, Clinical endpoint, Medicine, 030212 general & internal medicine, business, education, Adverse effect, ComputingMilieux_MISCELLANEOUS, medicine.drug
Abstract: Summary Background The use of cyclophosphamide in patients with acute exacerbation of idiopathic pulmonary fibrosis (IPF) is unknown. Our study was designed to evaluate the efficacy and safety of four cyclophosphamide pulses in addition to high-dose methylprednisolone in this population. Methods In this double-blind, placebo-controlled trial done in 35 departments across 31 hospitals in France, adult patients (≥18 years) with acute exacerbation of IPF and those with suspected acute exacerbation of IPF were randomly assigned in a 1:1 ratio using a web-based system to receive either intravenous pulses of cyclophosphamide (600 mg/m2) plus uromitexan as haemorrhagic cystitis prophylaxis (200 mg/m2) at the time of cyclophosphamide administration and then again, 4 h later, or placebo at days 0, 15, 30, and 60. Random assignment was stratified according to the severity of IPF and was block-balanced with variable block sizes of four or six patients. Patients receiving mechanical ventilation, with active infection, with active cancer, or who were registered on the lung transplant waiting list were excluded. All patients received standardised high-dose glucocorticoids. The investigators, patients, and the sponsor were masked to the treatment assignments. The primary endpoint was 3-month all-cause mortality, analysed by a χ2 test adhering to an intention-to-treat principle. The trial is now complete and registered with ClinicalTrials.gov , NCT02460588 . Findings Between Jan 22, 2016, and July 19, 2018, 183 patients were assessed for eligibility, of whom 120 patients were randomly assigned and 119 patients (62 [52%] with severe IPF) received at least one dose of cyclophosphamide (n=60) or placebo (n=59), all of whom were included in the intention-to-treat analysis. The 3-month all-cause mortality was 45% (27/60) in patients given cyclophosphamide compared with 31% (18/59) in the placebo group (difference 14·5% [95% CI −3·1 to 31·6]; p=0·10). Similar results were found after adjustment by IPF severity (odds ratio [OR] 1·89 [95% CI 0·89–4·04]). The risk of death at 3 months, independent of the treatment received, was higher with severe than non-severe IPF (OR 2·62 [1·12–6·12]) and was lower with the use of antifibrotic therapy (OR 0·33 [0·13–0·82]). Adverse events were similar between groups by 6 months (25 [42%] in the cyclophosphamide group vs 30 [51%] in the placebo group) and their proportion, including infections, did not differ. Overall infection was the main adverse event and occurred in 20 (33%) of 60 patients in the cyclophosphamide group versus 21 (36%) of 59 patients in the placebo group. Interpretation In patients with acute exacerbation of IPF, adding intravenous cyclophosphamide pulses to glucocorticoids increased 3-month mortality. These findings provide evidence against the use of intravenous cyclophosphamide in such patients. Funding Programme Hospitalier de Recherche Clinique of the French Ministry of Health (PHRC 2014–502), Roche Pharmaceuticals.
Published: 2022
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24. Beta-variant recombinant SARS CoV-2 vaccine induces durable cross-reactive antibodies against Omicron variants

Author: Odile Launay, Rachna Gupta, Tifany Machabert, Eleine Konate, Alexandra Rousseau, Vigne Claire, Francois Beckers, Roman Chicz, Elisabeth Botelho-Nevers, Marine Cachanado, Christian Chidiac, Dominique Deplanque, Bertrand Dussol, Inès Ben Ghezala, Marie Lachatre, Karine Lacombe, Fabrice Laine, Liem Binh Luong Nguyen, Patricia Pavese, Catherine Schmidt-Mutter, Marie-Pierre Tavolacci, Louis Devlin, Bogdana Coudsy, Saranya Srid, Amel Touati, Eric Tartour, and Tabassome Simon
Abstract: We previously reported the safety and immunogenicity data from a randomized trial comparing the monovalent (MV) recombinant protein Beta-variant (MVB.1.351) and MV ancestral protein (MVD614) booster vaccines with AS03 adjuvant (Sanofi/GSK) to mRNA BNT162b2 vaccine (Pfizer-BioNTech). First booster of the vaccines was administered in adult participants previously primed with 2 doses of BNT162b2. A subset of these participants with available blood samples collected at Day 0 (D0), at 28 days (D28), and 3 months (M3) post-booster were contacted for additional testing (195/208 participants). The persistence of cross-neutralizing antibodies, including against Omicron BA.1 and BA.4/5, up to 3 months after boosting was evaluated using a validated pseudovirus neutralization assay. The data showed that the MVB.1.351 vaccine induced higher and durable cross-neutralizing antibodies against Omicron subvariants up to 3 months after boosting compared to a MV ancestral and the mRNA BNT162b2 booster vaccine.
Published: 2023
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25. Which Patients may benefit from the Use of a Decision Support System to Improve Compliance of Physician Decisions with Clinical Practice Guidelines: A Case Study with Breast Cancer involving Data Mining.

Author: Brigitte Séroussi, Arnaud Soulet, Jean-Philippe Spano, Jean-Pierre Lefranc, Isabelle Cojean-Zelek, Brigitte Blaszka-Jaulerry, Laurent Zelek, Axel Durieux, Christophe Tournigand, Nizar Messai, Alexandra Rousseau, and Jacques Bouaud
Published: 2013
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26. Variability of factors associated with grip strength in hand osteoarthritis according to sex: Results from the DIGICOD cohort

Author: Elina Tan, Sophie Tuffet, Alexandra Rousseau, Bruno Fautrel, François Rannou, Francis Berenbaum, Jérémie Sellam, and Alice Courties
Subjects: Rheumatology
Published: 2023
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27. Feasibility of a repositioning schedule on pressure ulcer prevention in a French Intensive Care Unit: A pre and post-intervention pilot study

Author: Daisy Daigné, Pierre-Yves Blanchard, Marie-Cécile Allain, Gwendoline Lambert, Séverine Rodriguez, Benjamin Tessier, Clarisse Blayau, Guillaume Voiriot, Laurence Bérard, Alexandra Rousseau, and Muriel Fartoukh
Subjects: Dermatology, Pathology and Forensic Medicine
Abstract: As a prerequisite of a multicentre study, we conducted a pilot study to assess the feasibility of a daily repositioning schedule in critically ill patients. The schedule was adapted to the patient's clinical condition, and the estimated risk for developing a pressure ulcer using the Braden scale.A single-center pre and post-intervention pilot study in a French Intensive Care Unit of a university teaching hospital. This study followed TREND guidelines.During the first period (March to May 2018), pressure ulcer prevention was performed according to usual care. During the second period (June to August 2018), the repositioning schedule was adapted to the estimated risk for developing a pressure ulcer according to the Braden scale. Eligible patients had no pressure ulcer at baseline, were intubated within 24 hours of admission and expected to receive mechanical ventilation for at least 24 hours. The primary outcome was the rate of pressure ulcer development at 28 days of hospitalization or at discharge or death, as compared with usual care. Secondary outcomes included the feasibility and safety of the schedule, as assessed by caregivers' adherence and workload, and the rate of adverse events.In the pre-intervention period 20 participants were included, and 14 patients were included in the post-intervention period. There was no decrease in the pressure ulcers incidence with the intervention (25% vs. 28.6%; P = 1). The number of daily repositioning performed increased from 3.3 [IQR 3.0; 3.9] during the pre-intervention period to 4.3 [IQR 3.8; 5.2] during the post-intervention period (P 0.05), where it differed from the number scheduled by 0.6 [IQR 0.1; 1.4] per day, indicating satisfactory adherence of caregivers to the protocol. Adverse events rate did not differ between the two periods (55.9% vs. 57.1%; P = 0.90).A personalised daily repositioning schedule in critically ill patients is feasible and safe. The efficacy of such a strategy, together with its economic impact, need to be assessed in a multicentre randomized trial.
Published: 2022

28. Immunogenicity and Safety of Beta-Adjuvanted Recombinant Booster Vaccine

Author: Odile Launay, Marine Cachanado, Liem B. Luong Nguyen, Laetitia Ninove, Marie Lachâtre, Inès Ben Ghezala, Marc Bardou, Catherine Schmidt-Mutter, Karine Lacombe, Fabrice Laine, Jean-Sébastien Allain, Elisabeth Botelho-Nevers, Marie-Pierre Tavolacci, Christian Chidiac, Patricia Pavese, Bertrand Dussol, Stéphane Priet, Dominique Deplanque, Amel Touati, Laureen Curci, Eleine Konate, Nadine Ben Hamouda, Anissa Besbes, Eunice Nubret, Florence Capelle, Laurence Berard, Alexandra Rousseau, Eric Tartour, Tabassome Simon, Xavier de Lamballerie, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hôpital Cochin [AP-HP], Aix Marseille Université (AMU), Unité des Virus Emergents (UVE), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), CHU Strasbourg, Université Sorbonne Paris Nord, Hôpital Sud [CHU Rennes], CHU Pontchaillou [Rennes], Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Nutrition, Inflammation et axe Microbiote-Intestin-Cerveau (ADEN), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institute for Research and Innovation in Biomedicine (IRIB), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institute for Research and Innovation in Biomedicine (IRIB), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), UNIROUEN - UFR Santé (UNIROUEN UFR Santé), Normandie Université (NU)-Normandie Université (NU), Centre d'Investigation Clinique [CHU Rouen] (CIC Rouen), Hôpital Charles Nicolle [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hospices Civil de Lyon, CHU Grenoble, CHU Marseille, CHU Lille, Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), CHU Saint-Etienne, and douville, sabine
Subjects: Vaccines, Synthetic, Immunogenicity, Vaccine, Adjuvants, Immunologic, [SDV.MHEP.PHY] Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Immunization, Secondary, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Humans, General Medicine, Antibodies, Viral, ComputingMilieux_MISCELLANEOUS
Abstract: International audience
Published: 2022
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29. Effect of intravenous almitrine on intubation or mortality in patients with COVID-19 acute hypoxemic respiratory failure: A multicentre, randomised, double-blind, placebo-controlled trial

Author: Pierre Kalfon, Jean-François Payen, Alexandra Rousseau, Benjamin Chousterman, Marine Cachanado, Annick Tibi, Juliette Audibert, François Depret, Jean-Michel Constantin, Emmanuel Weiss, Francis Remerand, Yonathan Freund, Tabassome Simon, and Bruno Riou
Subjects: General Medicine
Abstract: Severe hypoxemia in patients with COVID-19 pneumonia might result from hypoxic pulmonary vasoconstriction, contributing to ventilation/perfusion (V/Q) mismatch. Because almitrine improves V/Q, it might reduce the risk for mechanical ventilation (MV) in such patients. Our primary objective was to determine the effect of almitrine on the need for MV at day 7.In a randomised double-blind placebo-controlled trial involving 15 ICUs, patients hospitalized for COVID-19 pneumonia and experiencing acute hypoxemic respiratory failure were randomly assigned to receive 5 days of intravenous low-dose (2 µg.kgBetween September 3, 2020 and September 25, 2021 181 patients were enrolled and randomly assigned to almitrine (n=89) or placebo (n=92). 179 patients (excluding two who withdrew from the study) were included in the intention-to-treat analysis (mean age: 60·1 years; 34% women) and analyzed. On day 7, the primary endpoint occurred in 32 patients assigned to almitrine (36%) and in 37 patients assigned to placebo (41%), for a difference of -4·3% (95% confidence interval: -18·7% to 10·2%). Secondary outcomes (28-day mortality, in-hospital mortality, ventilator-free days at day 28, days in the ICU and the hospital, and treatment discontinuation for pre-specified adverse effects) did not differ between the two groups.In patients with COVID-19 acute hypoxemic respiratory failure, low-dose almitrine failed in reducing the need for MV or death at day 7.Programme Hospitalier de Recherche Clinique (PHRC COVID 2020) funded by the French Ministry of Health, Les Laboratoires Servier (Suresnes, France) providing the study drug free of charge.
Published: 2022

30. Restrictive vs liberal red blood cell transfusion strategies in patients with acute myocardial infarction and anemia: Rationale and design of the <scp>REALITY</scp> trial

Author: Johanne Silvain, Manuel Martínez-Sellés, Reality Investigators, Gonzalo Calvo, Eric Vicaut, Nicolas Danchin, Cristina Avendaño-Solá, Philippe Gabriel Steg, Gregory Ducrocq, Joan Albert Arnaiz, Alexandra Rousseau, José Ramón González-Juanatey, Carma Karam, Marine Cachanado, Tabassome Simon, Etienne Puymirat, Gilles Lemesle, Isabelle Durand-Zaleski, Laboratoire de Recherche Vasculaire Translationnelle (LVTS (UMR_S_1148 / U1148)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Université Sorbonne Paris Nord, University of Barcelona, Universidade de Santiago de Compostela [Spain] (USC ), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Institut Coeur Poumon [CHU Lille], Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Universidad Complutense de Madrid = Complutense University of Madrid [Madrid] (UCM), CEREST-TC [CHU Saint-Antoine], CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Institute of cardiometabolism and nutrition (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hôpital Ambroise Paré [AP-HP], Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Ministère des Affaires Sociales et de la Santé PI15/01543 Instituto de Salud Carlos III, ISCIII Novartis AstraZeneca France Boehringer Ingelheim Pfizer Merck, The study is funded via a grant from the Programme de Recherche Médico‐Economique (PRME) from the French Ministry of Health, and a grant from the Instituto de Salud Carlos III (Spanish Ministry of Economy and Competitiveness), Grant n° PI15/01543., Editorial support was provided by Jenny Lloyd and Sophie Rushton‐Smith, MedLink Healthcare Communications, London, and was funded by the Programme de Recherche Medico‐Economique (PRME) from the Health Ministry in France., Dr Steg reports grants and nonfinancial support (cochair of the ODYSSEY OUTCOMES trial, as such, he received no personal fees, but his institution has received funding for the time he has devoted to trial coordination, and he has received support for travel related to trial meetings) from Sanofi, research grants and personal fees from Bayer (Steering Committee MARINER, grant for epidemiological study), Merck (speaker fees, grant for epidemiological studies), Sanofi (cochair of the ODYSSEY OUTCOMES trial, cochair of the SCORED trial, consulting, speaking), Servier (Chair of the CLARIFY registry, grant for epidemiological research), and Amarin (executive steering committee for the REDUCE‐IT trial [Disease Reduction of Cardiovascular Events With Icosapent Ethyl‐Intervention Trial], consulting), and and personal fees from Amgen, Bristol‐Myers Squibb, Boehringer Ingelheim, Pfizer, Novartis, Regeneron Pharmaceuticals, Lilly, and AstraZeneca. Dr Steg also has a European application number/patent number, issued on 26 October 2016 (no. 15712241.7), for a method for reducing cardiovascular risk.
Subjects: medicine.medical_specialty, Anemia, Cost effectiveness, medicine.medical_treatment, Trial Designs, Enfermedad cardiovascular, Myocardial Infarction, Ischemia, acute myocardial infarction, 030204 cardiovascular system & hematology, Revascularization, Hemoglobins, Tratamiento médico, 03 medical and health sciences, 0302 clinical medicine, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Reacción a la transfusión, Humans, Medicine, Blood Transfusion, cardiovascular diseases, 030212 general & internal medicine, Myocardial infarction, transfusion, Sistema cardiovascular, Transfusión sanguínea, cost effectiveness, business.industry, Insuficiencia cardíaca, General Medicine, medicine.disease, 3. Good health, Sample size determination, Relative risk, Emergency medicine, Erythrocyte Transfusion, Cardiology and Cardiovascular Medicine, business, Mace
Abstract: Background: Anemia is common in patients with acute myocardial infarction (AMI), and is an independent predictor of mortality. The optimal transfusion strategy in these patients is unclear. Hypothesis: We hypothesized that a "restrictive" transfusion strategy (triggered by hemoglobin ≤8 g/dL) is clinically noninferior to a "liberal" transfusion strategy (triggered by hemoglobin ≤10 g/dL), but is less costly. Methods: REALITY is an international, randomized, multicenter, open-label trial comparing a restrictive vs a liberal transfusion strategy in patients with AMI and anemia. The primary outcome is the incremental cost-effectiveness ratio (ICER) at 30 days, using the primary composite clinical outcome of major adverse cardiovascular events (MACE; comprising all-cause death, nonfatal stroke, nonfatal recurrent myocardial infarction, or emergency revascularization prompted by ischemia) as the effectiveness criterion. Secondary outcomes include the ICER at 1 year, and MACE (and its components) at 30 days and at 1 year. Results: The trial aimed to enroll 630 patients. Based on estimated event rates of 11% in the restrictive group and 15% in the liberal group, this number will provide 80% power to demonstrate clinical noninferiority of the restrictive group, with a noninferiority margin corresponding to a relative risk equal to 1.25. The sample size will also provide 80% power to show the cost-effectiveness of the restrictive strategy at a threshold of €50 000 per quality-adjusted life year. Conclusions: REALITY will provide important guidance on the management of patients with AMI and anemia. Sin financiación 3.287 JCR (2021) Q3, 74/143 Cardiac & Cardiovascular Systems 0.983 SJR (2021) Q1, 82/356 Cardiology and Cardiovascular Medicine No data IDR 2021 UEM
Published: 2021
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31. Health information technology: use it well, or don't! Findings from the use of a decision support system for breast cancer management.

Author: Jacques Bouaud, Brigitte Blaszka-Jaulerry, Laurent Zelek, Jean-Philippe Spano, Jean-Pierre Lefranc, Isabelle Cojean-Zelek, Axel Durieux, Christophe Tournigand, Alexandra Rousseau, and Brigitte Séroussi
Published: 2014

32. Economic evaluation of Restrictive Vs. Liberal Transfusion Strategy Following Acute Myocardial Infarction (REALITY): trial-based cost effectiveness and cost utility analyses

Author: Isabelle, Durand-Zaleski, Gregory, Ducrocq, Maroua, Mimouni, Jerome, Frenkiel, Cristina, Avendano-Solá, Jose R, Gonzalez-Juanatey, Emile, Ferrari, Gilles, Lemesle, Etienne, Puymirat, Laurence, Berard, Marine, Cachanado, Joan Albert, Arnaiz, Manuel, Martínez-Sellés, Johanne, Silvain, Albert, Ariza-Solé, Gonzalo, Calvo, Nicolas, Danchin, Sandra, Paco, Elodie, Drouet, Helene, Abergel, Alexandra, Rousseau, Tabassome, Simon, Philippe Gabriel, Steg, and Leticia Pereira, Gomez
Subjects: Health Policy, Cardiology and Cardiovascular Medicine
Abstract: Aims To estimate the cost–effectiveness and cost–utility ratios of a restrictive vs. liberal transfusion strategy in acute myocardial infarction (AMI) patients with anaemia. Methods and results Patients (n = 666) with AMI and haemoglobin between 7–8 and 10 g/dL recruited in 35 hospitals in France and Spain were randomly assigned to a restrictive (n = 342) or a liberal (n = 324) transfusion strategy with 1-year prospective collection of resource utilization and quality of life using the EQ5D3L questionnaire. The economic evaluation was based on 648 patients from the per-protocol population. The outcomes were 30-day and 1-year cost-effectiveness, with major adverse cardiovascular events (MACEs) averted as the effectiveness outcome. and a 1-year cost–utility ratio. The 30-day incremental cost–effectiveness ratio was €33 065 saved per additional MACE averted with the restrictive vs. liberal strategy, with an 84% probability for the restrictive strategy to be cost-saving and MACE-reducing (i.e. dominant). At 1 year, the point estimate of the cost–utility ratio was €191 500 saved per quality-adjusted life year gained; however, the cumulated MACE was outside the pre-specified non-inferiority margin, resulting in a decremental cost–effectiveness ratio with a point estimate of €72 000 saved per additional MACE with the restrictive strategy. Conclusion In patients with AMI and anaemia, the restrictive transfusion strategy was dominant (cost-saving and outcome-improving) at 30 days. At 1 year, the restrictive strategy remained cost-saving, but clinical non-inferiority on MACE was no longer maintained. Trial Registration ClinicalTrials.gov Identifier: NCT02648113. One sentence summary The use of a restrictive transfusion strategy in patients with acute myocardial infarction is associated with lower healthcare costs, but more evidence is needed to ascertain its long-term clinical impact.
Published: 2022

33. FC038: Efficacy of Levamisole for Maintaining Remission after the First Flare of Steroid Sensitive Nephrotic Syndrome in Children: The Nephrovir-3 Randomized Controlled Trial

Author: Claire Dossier, Theresa Kwon, Celia Nekrouf, Philippe Bensaid, Cyrielle Parmentier, Aurelien Galerne, Anne Chace, Sophie Gobet, Sylvie Nathanson, Fouad Mahdi, Ferielle Zenkhri, Sebastien Rouget, Olivia Boyer, Laurence Berard, Alexandra Rousseau, Julien Hogan, and Georges Deschenes
Subjects: Transplantation, Nephrology
Abstract: BACKGROUND AND AIMS In children with Steroid Sensitive Nephrotic Syndrome (SSNS), relapse after the first flare occurs in 80% of cases, whatever the dosage or duration of initial steroid therapy. Therefore, there is an unmet need for early interventions to reduce the incidence of relapse and subsequent steroids and immunosuppressive drug exposure. Levamisole is an antihelmintic drug with an immunomodulatory action that reduces relapses in children with frequent relapses or steroid-dependant NS. NEPHROVIR-3 is the first trial to assess the efficacy of levamisole in increasing duration of initial remission after the diagnosis of INS. METHOD NEPHROVIR-3 is a multicentric placebo-controlled randomized trial (1:1), in 38 centres of the Paris area, France. Patients were included at INS diagnosis and randomized, when steroid sensitive within 4 weeks, to receive either levamisole 2.5 mg/kg/48 h or placebo for 6 months, in addition to the French steroid protocol (18 weeks-3990 mg/m2). Primary outcome was the relapse-free survival at 1 year. The effect of the study drug was analysed by a Cox proportional hazard model stratified on centre. RESULTS Between September 2017 and February 2020, 86 patients were included, median age at INS onset was 5 years (IQ 3–7), with 69% of boys. At 4 weeks, 68 of them were randomized. Median time to remission was 8.5 days (IQ 6–12). Relapse-free survival at 12 months was 53.8% [95 confidence interval (95% CI) 34.7–69.5] in the levamisole group versus 20.9% (7.2–39.4) in the placebo group (P = .007). The risk of relapse associated with levamisole was HR = 0.37 (95% CI 0.15–0.89). CONCLUSION Early treatment with levamisole at the first flare of childhood SSNS significantly improves relapse-free survival at 1 year.
Published: 2022
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34. Whole exome sequencing in a cohort of familial premature ovarian insufficiency cases reveals a broad array of pathogenic or likely pathogenic variants in 50% of families

Author: Alexandre Rouen, Eli Rogers, Véronique Kerlan, Brigitte Delemer, Sophie Catteau-Jonard, Yves Reznik, Anne Gompel, Isabelle Cedrin, Anne-Marie Guedj, Virginie Grouthier, Thierry Brue, Catherine Pienkowski, Anne Bachelot, Sandra Chantot-Bastaraud, Alexandra Rousseau, Tabassome Simon, Esther Kott, Jean-Pierre Siffroi, Philippe Touraine, Sophie Christin-Maitre, Maladies génétiques d'expression pédiatrique (U933), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Universitaire de Reims (CHU Reims), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Hopital port Royal, Partenaires INRAE, Hôpital Jean Verdier [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Universitaire Carémeau [Nîmes] (CHU Nîmes), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Marseille medical genetics - Centre de génétique médicale de Marseille (MMG), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Marseille Maladies Rares (MarMaRa), Aix Marseille Université (AMU), Service d'endocrinologie, diabète, maladies métaboliques [Hôpital de la Conception - APHM], CHU Saint-Antoine [AP-HP], and Programme Hospitalier de Recherche Clinique AOM08084, NI07022 FAMIOP
Subjects: premature ovarian insufficiency, Genes in POI, [SDV]Life Sciences [q-bio], Menopause, Premature, Obstetrics and Gynecology, Primary Ovarian Insufficiency, hypergonadotropic hypogonadism, whole exome sequencing, Cohort Studies, Fragile X Mental Retardation Protein, Cross-Sectional Studies, primary amenorrhea, Reproductive Medicine, Exome Sequencing, Humans, Female
Abstract: International audience; Objective: To study the diagnostic yield, including variants in genes yet to be incriminated, of whole exome sequencing (WES) in familial cases of premature ovarian insufficiency (POI). Design: Cross-sectional study. Setting: Endocrinology and reproductive medicine teaching hospital departments. Patients: Familial POI cases were recruited as part of a nationwide multicentric cohort. A total of 36 index cases in 36 different families were studied. Fifty-two relatives were available, including 25 with POI and 27 affected who were nonaffected. Karyotype analysis, FMR1 screening, single nucleotide polymorphism array analysis, and WES were performed in all subjects. Interventions: None. Main Outcome Measures: The primary outcome was a molecular etiology, as diagnosed by karyotype, FMR1 screening, single nucleotide polymorphism array, and WES. Results: A likely molecular etiology (pathogenic or likely pathogenic variant) was identified in 18 of 36 index cases (50% diagnostic yield). In 12 families, we found a pathogenic or likely pathogenic variant in a gene previously incriminated in POI, and in 6 families, we found a pathogenic or likely pathogenic variant in new candidate genes. Most of the variants identified were located in genes involved in cell division and meiosis (n = 11) or DNA repair (n = 4). Conclusions: The genetic etiologic diagnosis in POI allows for genetic familial counseling, anticipated pregnancy planning, and ovarian tissue preservation or oocyte preservation. Identifying new genes may lead to future development of therapeutics in reproduction based on disrupted molecular pathways. Clinical Trial Registration Number: NCT 01177891. ((C) 2021 by American Society for Reproductive Medicine.) El resumen esta disponible en Espanol al final del articulo.
Published: 2022
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35. Recherche portant sur les soins courants (nouvelle catégorie dans la loi de 2004) : les raisons de l’échec

Author: Alexandra Rousseau, Serge Bureau, Marine Cachanado, Laurence Berard, François Lemaire, Tabassome Simon, Linghwei Tchon, Elodie Drouet, Camille Bocquillon, and Melissa Montil
Published: 2020
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36. One-Year Major Cardiovascular Events After Restrictive Versus Liberal Blood Transfusion Strategy in Patients With Acute Myocardial Infarction and Anemia: The REALITY Randomized Trial

Author: Jose R, Gonzalez-Juanatey, Gilles, Lemesle, Etienne, Puymirat, Gregory, Ducrocq, Marine, Cachanado, Joan Albert, Arnaiz, Manuel, Martínez-Sellés, Johanne, Silvain, Albert, Ariza-Solé, Emile, Ferrari, Gonzalo, Calvo, Nicolas, Danchin, Cristina, Avendano-Solá, Alexandra, Rousseau, Eric, Vicaut, Teba, Gonzalez-Ferrero, Philippe Gabriel, Steg, Tabassome, Simon, Universidade de Santiago de Compostela [Spain] (USC ), CHU Lille, Récepteurs Nucléaires, Maladies Métaboliques et Cardiovasculaires - U1011 (RNMCD), Institut Pasteur de Lille, Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Alliance française pour les essais cliniques cardio-vasculaires - French Alliance for Cardiovascular Trials (FACT), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Laboratoire de Recherche Vasculaire Translationnelle (LVTS (UMR_S_1148 / U1148)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord, CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Sorbonne Université (SU), Clinic Barcelona Hospital Universitari, Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition [CHU Pitié Salpêtrière] (IHU ICAN), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], Groupe Action, Institut de cardiologie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Bellvitge University Hospital [Barcelona, Spain], Hôpital Pasteur [Nice] (CHU), University of Barcelona, Hospital Universitario Puerta de Hierro-Majadahonda [Madrid, Spain], Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Diderot - Paris 7 (UPD7), Université Sorbonne Paris Cité (USPC), Royal Brompton Hospital, Centre de Ressources Biologiques APHP-SU (PASS-CRB-APHP-SU), Unité Mixte de Service Production et Analyse de données en Sciences de la vie et en Santé (PASS), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)
Subjects: anaemia, Time Factors, [SDV]Life Sciences [q-bio], major cardiovascular events, Myocardial Infarction, acute myocardial infarction, Anemia, Survival Analysis, Cardiovascular Diseases, Physiology (medical), Acute Disease, Humans, Blood Transfusion, prognosis, Cardiology and Cardiovascular Medicine, transfusion
Abstract: International audience; No abstract available
Published: 2022
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37. Does hyaluronic acid gel reduce intrauterine adhesions after dilation and curettage in women with miscarriage? A Multicentric randomized controlled trial (HYFACO Study)

Author: Jérémy Sroussi, Antoine Bourret, Anne-Gaëlle Pourcelot, Thibault Thubert, Magali Lesavre, Guillaume Legendre, Sophie Tuffet, Alexandra Rousseau, and Jean-Louis Benifla
Subjects: Abortion, Spontaneous, Uterine Diseases, Pregnancy, Obstetrics and Gynecology, Humans, Female, Tissue Adhesions, Hysteroscopy, Prospective Studies, Hyaluronic Acid, Dilatation, Gels, Curettage
Abstract: Miscarriage is a frequent problem that requires dilation and curettage in 30% of cases. This routine surgery may lead to intrauterine adhesions and severe infertility. Hyaluronic acid gel is known to reduce intrauterine adhesions after hysteroscopic surgery.This study aimed to evaluate the rate of intrauterine adhesions after dilation and curettage for miscarriage with and without hyaluronic acid gel.This was a multicentric (9 hospitals in France), prospective, open-label randomized trial. Patients who had a miscarriage between weeks 7 and 14 of gestation, required dilation and curettage, and wanted another pregnancy were eligible for the study. Women were randomly assigned in a 1:1 ratio to surgery alone (control group) or surgery with intrauterine instillation of hyaluronic acid gel (gel group). An office hysteroscopy was planned at 6 to 8 weeks after surgery. The primary endpoint was the rate of intrauterine adhesions during this office follow-up hysteroscopy. Two different follow-up fertility surveys were sent at 6 months and 1 year after the end of the intervention, respectively.Among the 343 patients who had curettage, 278 had hysteroscopy. After multiple imputation, the rate of intrauterine adhesions was lower in the gel group than in the control group (9.1% vs 18.4%, respectively; P=.0171). Among the 110 responders to the surveys, the overall pregnancy rate at 12 months after surgery was 64.5% (71/110), and similar in both groups (57.4% [27/47] in the control group vs 69.8% [44/63] in the gel group; P=.1789).Intrauterine instillation of hyaluronic acid gel reduces the rate of intrauterine adhesions in women treated with dilation and curettage for miscarriage.
Published: 2021

38. A prospective national cohort evaluating ring MVA vaccination as post-exposure prophylaxis for monkeypox

Author: Liem Binh Luong Nguyen, Jade Ghosn, Christine Durier, Carla Tachot, Eric Tartour, Amel Touati, Tabassome Simon, Brigitte Autran, Inmaculata Ortega Perez, Erica Telford, Jeremy K Ward, David Michels, Laurence Meyer, Alexandra Rousseau, Laurence Berard, Xavier de Lamballerie, Odile Launay, CIC Cochin Pasteur (CIC 1417), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôtel-Dieu-Groupe hospitalier Broca-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord, Institut National de la Santé et de la Recherche Médicale (INSERM), Paris-Centre de Recherche Cardiovasculaire (PARCC (UMR_S 970/ U970)), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université Sorbonne Paris Nord, Centre d'Immunologie et des Maladies Infectieuses (CIMI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), CERMES3 - Centre de recherche Médecine, sciences, santé, santé mentale, société (CERMES3 - UMR 8211 / U988 / UM 7), École des hautes études en sciences sociales (EHESS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), AIDES [Pantin, France], Coalition Internationale Sida PLUS [Pantin] (CISP), Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Unité des Virus Emergents (UVE), and Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: [SHS.SOCIO]Humanities and Social Sciences/Sociology, General Medicine, General Biochemistry, Genetics and Molecular Biology
Published: 2022
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39. Authors' reply

Author: Jean-Marc Naccache, Marine Cachanado, Alexandra Rousseau, and Hilario Nunes
Subjects: Pulmonary and Respiratory Medicine
Published: 2021

40. RCT Abstract - Cyclophosphamide added to glucocorticoids in acute exacerbation of idiopathic pulmonary fibrosis (EXAFIP): a randomized, double-blind, placebo-controlled, phase 3 trial

Author: Jean-Marc Naccache, Morgane Didier, Hilario Nunes, Julie Traclet, Olivia Freynet, Dominique Israel-Biet, Alexandre Chabrol, Arnaud Bourdin, Nathalie Bautin, Emmanuel Bergot, Grégoire Prévot, Jean Pastré, Sylvie Leroy, Philippe Bonniaud, Tristan Dégot, Frédéric Rivière, Raphael Borie, Cécile Chenivesse, Vincent Cottin, Lidwine Wemeau-Stervinou, Bruno Crestani, Martine Reynaud-Gaubert, Antoine Parrot, Dominique Valeyre, Marie-Christine Dombret, Malorie Kerjouan, Abdellatif Tazi, Anne Gondouin, Stéphane Jouneau, Elodie Blanchard, Sylvain Marchand-Adam, Sandrine Hirschi, C. Launois, Ana Nieves, Stéphane Dominique, François-Xavier Blanc, Jacques Cadranel, Marie-Pierre Debray, Anne-Sophie Gamez, Frédéric Gagnadoux, Marine Cachanado, Laurence Berard, Guillaume Beltramo, Tabassome Simon, Pierre-Yves Brillet, A. Gibelin, Emmanuel Gomez, Aurélie Le Borgne-Krams, François Lebargy, Alexandra Rousseau, and Laurent Plantier
Subjects: medicine.medical_specialty, Cyclophosphamide, Exacerbation, business.industry, medicine.disease, Placebo, Gastroenterology, law.invention, Double blind, Idiopathic pulmonary fibrosis, Randomized controlled trial, law, Internal medicine, Medicine, business, medicine.drug
Published: 2021
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41. The DIGICOD cohort: A hospital-based observational prospective cohort of patients with hand osteoarthritis - methodology and baseline characteristics of the population

Author: Bruno Fautrel, Anne Miquel, Francis Berenbaum, Amel Touati, Emmanuel Maheu, Michel D. Crema, Tabassome Simon, Bernard Combe, Maxime Dougados, Jean-Denis Laredo, Damien Loeuille, Xavier Chevalier, Sophie Tuffet, Alexandra Rousseau, Pascal Richette, Alice Courties, François Rannou, Margreet Kloppenburg, Jérémie Sellam, Service de rhumatologie [CHU Saint-Antoine], CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de Radiologie [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Service de pharmacologie - Dosage de médicaments [CHU Saint-Antoine], Service de rhumatologie [CHU Henri Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor, Département de Rhumatologie[Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Lapeyronie, Service de rhumatologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de rhumatologie [CHU Pitié Salpêtrière] (GRC-08 EEMOIS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Leiden University Medical Center (LUMC), Service de Rhumatologie [CHU Lariboisière], Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de Rhumatologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du rachis [CHU Cochin], Service de Neuroradiologie [CHU Lariboisière], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Lariboisière-Fernand-Widal [APHP]
Subjects: Male, medicine.medical_specialty, Hand Joints, Visual analogue scale, Population, Osteoarthritis, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, Interquartile range, Internal medicine, medicine, Crystal arthropathy, Humans, Prospective Studies, 030212 general & internal medicine, Prospective cohort study, education, Aged, 030203 arthritis & rheumatology, education.field_of_study, business.industry, Cohort, Middle Aged, medicine.disease, Hand, Hospitals, 3. Good health, Erosive hand osteoarthritis, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Female, business, Cohort study
Abstract: Objective: Despite its prevalence, there are few worldwide hand osteoarthritis (HOA) cohorts. The main objective of DIGItal COhort Design (DIGICOD) cohort is to investigate prognostic clinical, biological, genetic and imaging factors of clinical worsening after 6 years follow-up.Methods: DIGICOD is a hospital-based prospective cohort including patients > 35 years-old with symptomatic HOA fulfilling: (i) ACR criteria for HOA with > 2 symptomatic joints among proximal/distal interphalangeal joints or 1st interphalangeal joint with Kellgren-Lawrence (KL) > 2; or (ii) symptomatic thumb base OA with KL > 2. Main exclusion criteria were inflammatory arthritis and crystal arthropathies. Annual clinical evaluations were scheduled with imaging (X-rays of the hands and of other OA symptomatic joints) and biological sampling every 3 years. Hand radiographs are scored using KL and anatomical Verbruggen-Veys scores. Follow-up visits are ongoing. Cohort methodology and baseline characteristics are presented.Results: Between April 2013 and June 2017, from the 436 HOA included patients, 426 have been analysed of whom 357 (84%) are women. Mean age +/- standard deviation was 66.7 +/- 7.3 years and mean disease duration was 12.6 +/- 9.6 years. Metabolic syndrome affected 151 (36.5%) patients. Mean Visual Analog Scale (VAS) hand pain (0-100 mm) was 44.4 +/- 26.7 mm at activity. Mean FIHOA (0-100) was 19.9 + 18.6. Elevated serum CRP level (>= 5 mg/L) involved 10% patients. Mean KL score (0-128) was 46.7 +/- 18 and the mean number ofjoint with KL >= 2 was 15.1 +/- 6.3. Erosive HOA (defined as >= 1 Erosive or Remodeling phase joint according to Verbruggen-Veys score) involved 195/426 (45.8%) patients and the median number (interquartile range) of erosive joints in erosive patients was 3.0 (1.0-5.0).Conclusion: DIGICOD is a unique prospective HOA cohort with a long-term 6 years standardized assessment and has included severe radiologically HOA patients with a high prevalence of erosive disease. 2021 Societe francaise de rhumatologie. Published by Elsevier Masson SAS. All rights reserved.
Published: 2021
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42. High-risk exposure without personal protective equipment and infection with SARS-CoV-2 in-hospital workers - The CoV-CONTACT cohort

Author: Xavier, Duval, Charles, Burdet, Bruno, Lina, Sarah, Tubiana, Sylvie, Van Der Werf, Fanny, Abad, Dominique, Abry, Loubna, Alavoine, Jean-Sébastien, Allain, Karline, Amiel-Taieb, Pierre, Audoin, Shana, Augustin, Sandrine, Ayala, Hélène, Bansard, Fréderique, Bertholon, Nolwenn, Boissel, Elisabeth, Botelho-Nevers, Kévin, Bouiller, Marilou, Bourgeon, Mathilde, Boutrou, Lysiane, Brick, Léa, Bruneau, Eric, Caumes, Agnès, Chabouis, Eric, Chan Thien, Catherine, Chirouze, Bruno, Coignard, Yolande, Costa, Virginie, Costenoble, Sylvie, Cour, Claire, Cracowski, Luc, Cracowski Jean, Dominique, Deplanque, Stéphane, Dequand, Mireille, Desille-Dugast, Maxime, Desmarets, Maelle, Detoc, Marie, Dewitte, Felix, Djossou, Jean-Luc, Ecobichon, Elise, Elrezzi, William, Faurous, Viviane, Fortuna, Julie, Fouchard, Emilie, Gantier, Céline, Gautier, Patrick, Gerardin, Sandrine, Gerset, Marie, Gilbert, Valérie, Gissot, Francis, Guillemin, Cédric, Hartard, Béatrice, Hazevis, Didier, Hocquet, Enkelejda, Hodaj, Emila, Ilic-Habensus, Jeudy, A, Helene, Jeulin, Maty, Kane, Emmanuelle, Kasprzyk, John, Kikoine, Fabrice, Laine, Bruno, Laviolle, David, Lebeaux, Anne, Leclercq, Eric, Ledru, Benjamin, Lefevre, Carole, Legoas, Amélie, Legrand, Karine, Legrand, Jonathan, Lehacaut, Claire, Lehur, Dalila, Lemouche, Quentin, Lepiller, Sévérine, Lepuil, Estelle, Letienne, Aude, Lucarelli, Jean-Christophe, Lucet, Isabelle, Madeline, Adrien, Maillot, Catherine, Malapate, Denis, Malvy, Milica, Mandic, Solène, Marty-Quinternet, Mohamed, Meghadecha, Mayka, Mergeay-Fabre, Pauline, Mespoulhe, Alexandre, Meunier, Maria-Claire, Migaud, Justina, Motiejunaite, Gay, Nathalie, Duc, Nguyen, Soumaya, Oubbea, Maïder, Pagadoy, Adeline, Paris, Christophe, Paris, Christine, Payet, Nathan, Peiffer-Smadja, Lucas, Perez, Pauline, Perreau, Nathalie, Pierrez, Thierry, Pistone, Andreea, Postolache, Patrick, Rasoamanana, Cécile, Reminiac, Jade, Rexah, Elise, Roche-Gouanvic, Alexandra, Rousseau, Betty, Schoemaecker, Sandrine, Simon, Catherine, Soler, Stéphanie, Somers, Khaly, Sow, Bernard, Tardy, Zaven, Terzian, Michael, Thy, Anne, Tournier, Sandrine, Tyrode, Charline, Vauchy, Renaud, Verdon, Pauline, Vernet, Valérie, Vignali, Nawal, Waucquier, Huong, Do Thi Thu, Cédric, Laouénan, France, Mentre, Manchon, Pauline, Aline, Dechanet, Sophie, Letrou, Caroline, Quintin, Wahiba, Frezouls, Quentin, Le Hingrat, Nadhira, Houhou, Florence, Damond, Dianes, Descamps, Charlotte, Charpentier, Benoit, Visseaux, Astrid, Vabret, Maud, Bouscambert, Sylvie, Behillil, Laurence, Gaillanne, Nabil, Benmalek, Mikael, Attia, Marion, Barbet, Caroline, Demeret, Thierry, Rose, Stéphane, Petres, Nicolas, Escriou, Sophie, Goyard, Ouifiya, Kafif, Valentine, Piquard, Alexandra, Mailles, Anne, Simondon, Marion, Dreyere, Bruno, Morel, Thiphaine, Vesval, Karine, Amat, Douae, Ammour, Khadija, Aqourras, Sandrine, Couffin-Cadiergues, Christelle, Delmas, Vristi, Desan, Michel, Doute Jean, Hélène, Esperou, Samia, Hendou, Christelle, Kouakam, Guillaume, Le Meut, Soizic, Lemestre, Nicolas, Leturque, Emmanuelle, Marcoul, Solange, Nguefang, Layidé, Roufai, Abel, Laurent, Caillat-Zucman, Sophie, Tubiana, Sarah, Burdet, Charles, Houhou, Nadhira, Thy, Michael, Blanquart, François, Charpentier, Charlotte, Guedj, Jérémie, Alavoine, Loubna, Behillil, Sylvie, Leclercq, Anne, Lucet, Jean-Christophe, Yazdanpanah, Yazdan, Attia, Mikaël, Demeret, Caroline, Rose, Thierry, Bielicki, Julia Anna, Bruijning-Verhagen, Patricia, Goossens, Herman, Descamps, Diane, van der Werf, Sylvie, Lina, Bruno, and Duval, Xavier
Published: 2021
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43. High-Dose Rituximab and Early Remission in PLA2R1-Related Membranous Nephropathy

Author: Hanna Debiec, Christelle Zaghrini, Alessandra Rosenthal, Michel Ticchioni, Karine Dahan, Gérard Lambeau, Alexandra Rousseau, Barbara Seitz-Polski, Vincent L.M. Esnault, Marine Andreani, Ghislaine Bernard, Pierre Ronco, Sylvia Benzaken, Departement d'immunologie, hôpital de l'Archet, CHU de Nice, Département de Néphrologie - Hôpital Pasteur [Nice], Hôpital Pasteur [Nice] (CHU), Institut de pharmacologie moléculaire et cellulaire (IPMC), Centre National de la Recherche Scientifique (CNRS)-Université Nice Sophia Antipolis (... - 2019) (UNS), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-Université Côte d'Azur (UCA), Service de Néphrologie et Dialyses [CHU Tenon], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Tenon [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU Tenon [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Sorbonne Université (SU), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Département d'Immunologie, Centre Hospitalier Universitaire de Nice (CHU de Nice)-Groupe hospitalier l'Archet (Nice), Laboratoire Immunologie [Nice], Hôpital de l'Archet-Université Côte d'Azur (UCA)-Université Nice Sophia Antipolis (... - 2019) (UNS), and COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)
Subjects: Male, medicine.medical_specialty, Epidemiology, 030232 urology & nephrology, Nice, Early remission, Critical Care and Intensive Care Medicine, Glomerulonephritis, Membranous, Gastroenterology, Cohort Studies, Epitopes, 03 medical and health sciences, 0302 clinical medicine, Membranous nephropathy, Interquartile range, [SDV.BBM.GTP]Life Sciences [q-bio]/Biochemistry, Molecular Biology/Genomics [q-bio.GN], Internal medicine, medicine, Immunologic Factors, Humans, Prospective Studies, ComputingMilieux_MISCELLANEOUS, Aged, 030304 developmental biology, computer.programming_language, Epitope spreading, 0303 health sciences, Transplantation, business.industry, Receptors, Phospholipase A2, Remission Induction, Editorials, Original Articles, Middle Aged, 16. Peace & justice, medicine.disease, 3. Good health, Nephrology, Cohort, Female, Rituximab, business, computer, medicine.drug, Cohort study
Abstract: BACKGROUND AND OBJECTIVES: Different rituximab protocols are used to treat membranous nephropathy. We compared two rituximab protocols in patients with membranous nephropathy. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Twenty-eight participants from the NICE cohort received two infusions of 1-g rituximab at 2-week intervals, whereas 27 participants from the Prospective Randomized Multicentric Open Label Study to Evaluate Rituximab Treatment for Membranous Nephropathy (GEMRITUX) cohort received two infusions of 375 mg/m(2) at 1-week interval. We measured serum rituximab levels and compared remission at month 6 and before any treatment modification and analyzed factors associated with remission and relapses. RESULTS: Remissions occurred in 18 (64%) versus eight (30%) from the NICE and GEMRITUX cohort (P=0.02) at month 6, respectively, and in 24 (86%) versus 18 (67%) participants (P=0.12) before treatment modification, respectively. Median time to remission was 3 [interquartile range (IQR), 3–9] and 9 [IQR, 6–12] months for NICE and GEMRITUX cohorts respectively (P=0.01). Participants from the NICE cohort had higher circulating level of rituximab and lower CD19 counts (3.3 µg/L [IQR, 0.0–10.8] versus 0.0 [IQR, 0.0–0.0] P
Published: 2019
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44. Force de préhension dans la cohorte d’arthrose digitale symptomatique DIGICOD : un marqueur de sévérité arthrosique chez les femmes, un marqueur de comorbidités chez les hommes

Author: Bruno Fautrel, Francis Berenbaum, T. Elina, Alice Courties, Alexandra Rousseau, François Rannou, Sophie Tuffet, and Jérémie Sellam
Subjects: Rheumatology
Published: 2021
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45. LDL-apheresis to decrease sFlt-1 during early severe preeclampsia: Report of two cases from a discontinued phase II trial

Author: Jean Guibourdenche, Samir Saheb, Eric Rondeau, Anthony Corchia, Cédric Rafat, Marie Bornes, Vassilis Tsatsaris, Bassam Haddad, Camille Petit-Hoang, Alexandre Hertig, Guillaume Lefèvre, Edouard Lecarpentier, Thomas Robert, Tabassome Simon, Alexandra Rousseau, Frederic Richard, CHI Créteil, Service de gynécologie et obstétrique [Créteil], Service de biochimie et hormonologie [CHU Tenon], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Tenon [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Urgences néphrologiques et transplantation rénale [CHU Tenon], CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Gynécologie-obstétrique et médecine de la reproduction - Maternité [CHU Tenon], CHU Tenon [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de Gynécologie et Obstétrique [Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Cochin [AP-HP], Sorbonne Université - Faculté de Médecine (SU FM), and Sorbonne Université (SU)
Subjects: Adult, medicine.medical_specialty, Gestational Age, sFlt-1, [SDV.MHEP.GEO]Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics, 030204 cardiovascular system & hematology, Preeclampsia, Sepsis, 03 medical and health sciences, Fatal Outcome, 0302 clinical medicine, Pre-Eclampsia, Pregnancy, LDL-apheresis, medicine, Humans, Prospective Studies, 030212 general & internal medicine, Prospective cohort study, Vascular Endothelial Growth Factor Receptor-1, business.industry, Obstetrics, Infant, Newborn, Pregnancy Outcome, Obstetrics and Gynecology, Gestational age, medicine.disease, 3. Good health, Lipoproteins, LDL, Apheresis, Reproductive Medicine, LDL apheresis, Hypertension, Blood Component Removal, Premature Birth, Gestation, Female, business
Abstract: International audience; Objective: Severe preeclampsia may require the delivery of the placenta to avoid life-threatening complications for the mother. Before 26 weeks of gestation, this often results in perinatal death. A decrease in soluble fms-like tyrosine kinase 1 (sFlt1), an anti-angiogenic factor central to the pathophysiology of the maternal syndrome, has been reported after LDL- apheresis. The present study tested whether LDL-apheresis could be used to allow women with early and severe preeclampsia to reach a gestational age where the baby had a viable chance of survival.Study Design: A phase II prospective study. Adult women were included if they had very early (
Published: 2018
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46. Metacarpophalangeal Joint Impairment in Hand Osteoarthritis and Its Association With Mechanical Factors: Results From the Digital Cohort Osteoarthritis Design Hand Osteoarthritis Cohort

Author: Francis Berenbaum, Alice Courties, Michel D. Crema, Alexandra Rousseau, Inès Kouki, Maxime Dougados, Jérémie Sellam, Sophie Tuffet, and Pascal Richette
Subjects: Male, medicine.medical_specialty, Hand Joints, Population, Patient characteristics, 02 engineering and technology, Osteoarthritis, Logistic regression, 01 natural sciences, Cohort Studies, Metacarpophalangeal Joint, Rheumatology, Internal medicine, 0202 electrical engineering, electronic engineering, information engineering, Medicine, Humans, education, Aged, education.field_of_study, business.industry, 010401 analytical chemistry, 020206 networking & telecommunications, Middle Aged, medicine.disease, Hand, 0104 chemical sciences, Radiography, Cross-Sectional Studies, Cohort, Female, Metabolic syndrome, Interphalangeal Joint, business, Hand osteoarthritis
Abstract: Objective: To determine the prevalence, distribution and characteristics associated with radiographic metacarpophalangeal (MCP) osteoarthritis (OA). Methods: This is a cross‐sectional study of baseline data from the DIGItal Cohort Osteoarthritis Design, a French monocentric cohort including patients with symptomatic hand OA (HOA). We evaluated the prevalence of radiographic MCP OA defined as ≥2 MCP joints with a Kellgren and Lawrence score ≥2. We compared the prevalence of MCP OA in the dominant and non‐dominant hands. Associations between radiographic MCP OA and patient characteristics were studied using univariable and multivariable logistic regression. Results: Radiographic MCP OA was present in 138 of the 425 patients (32.5%) but was not severe. Patients with MCP OA had a mean age of 69.2±6.9 years, a BMI of 25±4.2 kg/m2, and 86.2% were women. MCP OA was more frequent in the dominant hand and predominated at the 1st and 2nd MCP joints. In the multivariable analysis, MCP OA was associated with older age (OR 1.05, 95%CI [1.01,1.10] for each year), manual occupation (OR 3.74, 95%CI [1.21,11.54]), scaphotrapezial OA (OR 2.18, 95%CI [1.27,3.72]), and a high number of proximal interphalangeal joints with radiographic OA. MCP OA was not associated with metabolic syndrome or HOA symptoms. Conclusion: In this cross‐sectional study using a hospital‐based HOA cohort, radiographic MCP OA was frequent and associated with structural HOA features rather than with symptom severity. Our results suggest that the involvement of MCP joints in HOA is predominantly related to mechanical rather than systemic factors in this population.
Published: 2021

47. Combined use of a broad-panel respiratory multiplex PCR and procalcitonin to reduce duration of antibiotics exposure in patients with severe community-acquired pneumonia (MULTI-CAP): a multicentre, parallel-group, open-label, individual randomised trial conducted in French intensive care units

Author: Guillaume, Voiriot, Muriel, Fartoukh, Isabelle, Durand-Zaleski, Laurence, Berard, Alexandra, Rousseau, Laurence, Armand-Lefevre, Charlotte, Verdet, Laurent, Argaud, Kada, Klouche, Bruno, Megarbane, Juliette, Patrier, Jean-Christophe, Richard, Jean, Reignier, Carole, Schwebel, Bertrand, Souweine, Yacine, Tandjaoui-Lambiotte, Tabassome, Simon, Jean-François, Timsit, Saad, Nseir, CarMeN, laboratoire, Service de Réanimation et USC Médico-Chirurgicale = Médecine intensive réanimation [CHU Tenon], CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Unité de recherche clinique en économie de la santé [Paris] (URC Eco), Délégation de la Recherche Clinique et de l’Innovation [Paris] (DRCI), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Unité de Recherche Clinique de l’Est Parisien [CHU Saint-Antoine] (URC-EST), Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts (CHNO)-CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Rothschild [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Direction de la Recherche Clinique et de l'Innovation [AP-HP] (DRCI), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de microbiologie [CHU Bichat], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Nord Val de Seine, Service de microbiologie [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Hôpital Edouard Herriot [CHU - HCL], Hospices Civils de Lyon (HCL), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Hôpital Lariboisière-Fernand-Widal [APHP], AP-HP - Hôpital Bichat - Claude Bernard [Paris], Hôpital de la Croix-Rousse [CHU - HCL], Centre hospitalier universitaire de Nantes (CHU Nantes), Université Grenoble Alpes - UFR Médecine (UGA UFRM), Université Grenoble Alpes (UGA), CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand, Hôpital Avicenne [AP-HP], CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université Pierre et Marie Curie - Paris 6 (UPMC), MULTI-CAP study group: Keyvan Razazi, Jean Dellamonica, Jean-Christophe Navellou, Pierre-Francois Dequin, Pierre-Edouard Bollaert, Marc Gainnier, Julien Bohe, Eric Maury, Saad Nseir., Service de Réanimation et USC Médico-Chirurgicale [CHU Tenon], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), and Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Trousseau [APHP]
Subjects: Adult, adult thoracic medicine, [SDV]Life Sciences [q-bio], Intensive Care, COVID-19, respiratory infections, Pneumonia, diagnostic microbiology, Anti-Bacterial Agents, molecular diagnostics, [SDV] Life Sciences [q-bio], Intensive Care Units, Humans, Multiplex Polymerase Chain Reaction, Procalcitonin, adult intensive & critical care
Abstract: International audience; INTRODUCTION: At the time of the worrying emergence and spread of bacterial resistance, reducing the selection pressure by reducing the exposure to antibiotics in patients with community-acquired pneumonia (CAP) is a public health issue. In this context, the combined use of molecular tests and biomarkers for guiding antibiotics discontinuation is attractive. Therefore, we have designed a trial comparing an integrated approach of diagnosis and treatment of severe CAP to usual care. METHODS AND ANALYSIS: The multiplex PCR and procalcitonin to reduce duration of antibiotics exposure in patients with severe-CAP (MULTI-CAP) trial is a multicentre (n=20), parallel-group, superiority, open-label, randomised trial. Patients are included if adult admitted to intensive care unit for a CAP. Diagnosis of pneumonia is based on clinical criteria and a newly appeared parenchymal infiltrate. Immunocompromised patients are excluded. Subjects are randomised (1:1 ratio) to either the intervention arm (experimental strategy) or the control arm (usual strategy). In the intervention arm, the microbiological diagnosis combines a respiratory multiplex PCR (mPCR) and conventional microbiological investigations. An algorithm of early antibiotic de-escalation or discontinuation is recommended, based on mPCR results and the procalcitonin value. In the control arm, only conventional microbiological investigations are performed and antibiotics de-escalation remains at the clinician's discretion. The primary endpoint is the number of days alive without any antibiotic from the randomisation to day 28. Based on our hypothesis of 2 days gain in the intervention arm, we aim to enrol a total of 450 patients over a 30-month period. ETHICS AND DISSEMINATION: The MULTI-CAP trial is conducted according to the principles of the Declaration of Helsinki, is registered in Clinical Trials and has been approved by the Committee for Protection of Persons and the National French Drug Safety Agency. Written informed consents are obtained from all the patients (or representatives). The results will be disseminated through educational institutions, submitted to peer-reviewed journals for publication and presented at medical congresses. TRIAL REGISTRATION NUMBER: NCT03452826; Pre-results.
Published: 2021
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48. Immunogenicity and Reactogenicity of Heterologous and Homologous mRNA-1273 and BNT162b2 Vaccination: A Multicenter Non-Inferiority Randomized Trial

Author: Cécile Janssen, Marine Cachanado, Laetitia Ninove, Marie Lachatre, Jocelyn Michon, Olivier Epaulard, Zoha Maakaroun-Vermesse, Christian Chidiac, Bruno Laviolle, Hugues Aumaitre, Ady Assaf, Karine Lacombe, Catherine Schmidt-Mutter, Elisabeth Botelho-Nevers, Magali Briere, Thomas Boisson, Paul Loubet, Boris Bienvenu, Olivier Bouchaud, Amel Touati, Christine Pereira, Alexandra Rousseau, Laurence Berard, Melissa Montil, Xavier de Lamballerie, Tabassome Simon, Odile Launay, and The ARNCOMBI Study Group
Subjects: History, Polymers and Plastics, Business and International Management, Industrial and Manufacturing Engineering
Published: 2021
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49. Case Report: Emergence of Candida auris in the Indian Ocean Region

Author: Jérôme Allyn, Laura Teysseyre, Nicolas Allou, Guillaume Miltgen, Nathalie Lugagne, Nicolas Traversier, Yael Levy, Alexandra Rousseau, Marie Desnos-Ollivier, Centre Hospitalier Universitaire de La Réunion (CHU La Réunion), Processus Infectieux en Milieu Insulaire Tropical (PIMIT), Centre National de la Recherche Scientifique (CNRS)-IRD-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de La Réunion (UR), Mycologie moléculaire - Molecular Mycology, Centre National de la Recherche Scientifique (CNRS)-Institut Pasteur [Paris], Centre National de Référence Mycoses Invasives et Antifongiques - National Reference Center Invasive Mycoses & Antifungals (CNRMA), Institut Pasteur [Paris], Desnos-Ollivier, Marie, Université de La Réunion (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IRD-Centre National de la Recherche Scientifique (CNRS), Institut Pasteur [Paris] (IP)-Centre National de la Recherche Scientifique (CNRS), and Institut Pasteur [Paris] (IP)
Subjects: Adult, Male, medicine.medical_specialty, Antifungal Agents, Asia, media_common.quotation_subject, 030231 tropical medicine, Global Health, law.invention, 03 medical and health sciences, 0302 clinical medicine, law, Hygiene, Virology, Internal medicine, Humans, Medicine, Candidiasis, Invasive, Colonization, Indian Ocean, [SDV.MP.MYC]Life Sciences [q-bio]/Microbiology and Parasitology/Mycology, Aged, media_common, Aged, 80 and over, business.industry, Nosocomial transmission, Outbreak, Articles, Candida auris, Intensive care unit, [SDV.MP.MYC] Life Sciences [q-bio]/Microbiology and Parasitology/Mycology, 3. Good health, Indian ocean, Infectious Diseases, Infected patient, Female, Parasitology, Travel-Related Illness, business
Abstract: Candida auris is an emerging multidrug-resistant yeast that can cause severe infections and spread easily between hospitalized patients, leading to outbreaks in hospital. Here, we report the first four cases of colonization and invasive infection with C. auris reported in the Indian Ocean region. All cases were observed in the French overseas Reunion Island, a very popular destination for European travelers. Three patients had urinary tract or skin colonization, and one had a fatal invasive infection. In three cases, including that of the infected patient, the yeast was not initially identified as C. auris, preventing specific hygiene measures to be implemented as suggested in the December 2016 clinical alert to European healthcare facilities. The infected patient likely acquired C. auris in the intensive care unit from the first colonized patient. This is the first case of C. auris infection and the first potential case of nosocomial transmission of the pathogen to be reported in the French overseas Reunion Island.
Published: 2020
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50. Randomised trial of first-line bronchial artery embolisation for non-severe haemoptysis of mild abundance

Author: Benjamin Planquette, Vincent Labbe, Tabassome Simon, Alexandra Rousseau, Jacques Cadranel, Antoine Khalil, Emmanuel Bergot, Gérard Zalcman, Guy Meyer, Philippe Cluzel, Vincent Jounieaux, Alexandre Demoule, Muriel Fartoukh, Aude Gibelin, Olivier Sanchez, THOMAS SIMILOWSKI, Claire Andrejak, Valérie Chabbert, Michel Djibré, Sophie Tuffet, Cendrine Godet, Sandrine Pontier-Marchandise, Julien Mayaux, Marc Sapoval, Vincent Le Pennec, Clarisse Blayau, Guillaume Voiriot, Alexandre Duguet, Hélène Prodanovik, Guillaume Briend, Anne Roche, Costantino Del Giudice, Olivier Pellerin, Marie-Pierre Revel, Patrick Courtheoux, Jean Claude Meurice, Elise Antone, Alexandre Remond, Service de Pneumologie - Oncologie Thoracique - Maladies Pulmonaires Rares [CHU Tenon], CHU Tenon [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de Pneumologie - R3S [CHU Pitié-Salpêtrière] (SPMIR-R3S), CHU Pitié-Salpêtrière [AP-HP], Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Unité de Recherche Clinique de l’Est Parisien [CHU Saint-Antoine] (URC-EST), Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts (CHNO)-CHU Tenon [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Rothschild [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de pneumologie [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Université de Picardie Jules Verne (UPJV), Service de pneumologie [Toulouse], CHU Toulouse [Toulouse]-Hôpital Larrey [Toulouse], CHU Toulouse [Toulouse], Service d'Anesthésie réanimation [CHU Tenon], Service de radiologie cardiovasculaire et interventionnelle [CHU Pitié-Salpêtrière], Service de Radiologie [CHU HEGP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Service de Radiologie [CHU Caen], Service de Radiologie [CHU Tenon], Service de Pneumologie et Réanimation Médicale [CHU Pitié-Salpêtrière] (Département ' R3S '), Service de Radiothérapie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Tenon [AP-HP]
Subjects: Adult, Pulmonary and Respiratory Medicine, Hemoptysis, medicine.medical_specialty, Standard of care, First line, Bronchial Arteries, Imaging/CT MRI etc, Pulmonary Vasculature, 030218 nuclear medicine & medical imaging, Diseases of the respiratory system, 03 medical and health sciences, 0302 clinical medicine, Primary outcome, Bronchoscopy, medicine.artery, medicine, Humans, Adverse effect, Trial registration, Retrospective Studies, RC705-779, medicine.diagnostic_test, Adult patients, business.industry, Embolization, Therapeutic, 3. Good health, Surgery, Treatment Outcome, 030228 respiratory system, Medicine, business, Bronchial artery, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Massive Haemoptysis
Abstract: BackgroundWhereas first-line bronchial artery embolisation (BAE) is considered standard of care for the management of severe haemoptysis, it is unknown whether this approach is warranted for non-severe haemoptysis.Research questionTo assess the efficacy on bleeding control and the safety of first-line BAE in non-severe haemoptysis of mild abundance.Study design and methodsThis multicentre, randomised controlled open-label trial enrolled adult patients without major comorbid condition and having mild haemoptysis (onset ResultsBleeding recurrence at day 30 after randomisation (primary outcome) occurred in 4 (11.8%) of 34 patients in the BAE strategy and 17 (44.7%) of 38 patients in the medical strategy (difference −33%; 95% CI −13.8% to −52.1%, p=0.002). The 90-day bleeding recurrence-free survival rates were 91.2% (95% CI 75.1% to 97.1%) and 60.2% (95% CI 42.9% to 73.8%), respectively (HR=0.19, 95% CI 0.05 to 0.67, p=0.01). No death occurred during follow-up and no bleeding recurrence needed surgery.Four adverse events (one major with systemic emboli) occurred during hospitalisation, all in the BAE strategy (11.8% vs 0%; difference 11.8%, 95% CI 0.9 to 22.6, p=0.045); all eventually resolved.ConclusionIn non-severe haemoptysis of mild abundance, BAE associated with medical therapy had a superior efficacy for preventing bleeding recurrences at 30 and 90 days, as compared with medical therapy alone. However, it was associated with a higher rate of adverse events.Trial registration numberNCT01278199
Published: 2020
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