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1. The DAV132 colon-targeted adsorbent does not interfere with plasma concentrations of antibiotics but prevents antibiotic-related dysbiosis: a randomized phase I trial in healthy volunteers

Author

Messaoudene, Meriem, Ferreira, Stéphanie, Saint-Lu, Nathalie, Ponce, Mayra, Truntzer, Caroline, Boidot, Romain, Le Bescop, Clément, Loppinet, Thomas, Corbel, Tanguy, Féger, Céline, Bertrand, Karine, Elkrief, Arielle, Isaksen, Morten, Vitry, Fabien, Sablier-Gallis, Frédérique, Andremont, Antoine, Bod, Lloyd, Ghiringhelli, François, de Gunzburg, Jean, and Routy, Bertrand

Published
2024
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3. Abstract 5882: Prevention of antibiotic-induced dysbiosis in human volunteers by DAV132 and preservation of responsiveness to anti-PD-1 demonstrated by transplantation of human feces into tumor-bearing mice

Author

Messaoudene, Meriem, primary, Saint-Lu, Nathalie, additional, Sablier-Gallis, Frédérique, additional, Ferreira, Stéphanie, additional, Ponce, Mayra, additional, Bescop, Clément Le, additional, Loppinet, Thomas, additional, Corbel, Tanguy, additional, Féger, Céline, additional, Vitry, Fabien, additional, Andremont, Antoine, additional, de Gunzburg, Jean, additional, and Routy, Bertrand, additional

Published
2023
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6. An open randomized multicentre Phase 2 trial to assess the safety of DAV132 and its efficacy to protect gut microbiota diversity in hospitalized patients treated with fluoroquinolones

Author

Vehreschild, Maria J. G. T., Ducher, Annie, Louie, Thomas, Cornely, Oliver A., Feger, Celine, Dane, Aaron, Varastet, Marina, Vitry, Fabien, de Gunzburg, Jean, Andremont, Antoine, Mentre, France, Wilcox, Mark H., Vehreschild, Maria J. G. T., Ducher, Annie, Louie, Thomas, Cornely, Oliver A., Feger, Celine, Dane, Aaron, Varastet, Marina, Vitry, Fabien, de Gunzburg, Jean, Andremont, Antoine, Mentre, France, and Wilcox, Mark H.

Abstract

Background DAV132 (colon-targeted adsorbent) has prevented antibiotic-induced effects on microbiota in healthy volunteers. Objectives To assess DAV132 safety and biological efficacy in patients. Patients and methods An open-label, randomized [stratification: fluoroquinolone (FQ) indication] multicentre trial comparing DAV132 (7.5 g, 3 times a day, orally) with No-DAV132 in hospitalized patients requiring 5-21 day treatment with FQs and at risk of Clostridioides difficile infection (CDI). FQ and DAV132 were started simultaneously, DAV132 was administered for 48 h more, and patients were followed up for 51 days. The primary endpoint was the rate of adverse events (AEs) independently adjudicated as related to DAV132 and/or FQ. The planned sample size of 260 patients would provide a 95% CI of +/- 11.4%, assuming a 33% treatment-related AE rate. Plasma and faecal FQ concentrations, intestinal microbiota diversity, intestinal colonization with C. difficile, MDR bacteria and yeasts, and ex vivo resistance to C. difficile faecal colonization were assessed. Results Two hundred and forty-three patients (median age 71 years; 96% with chronic comorbidity) were included (No-DAV132, n = 120; DAV132, n = 123). DAV132- and/or FQ-related AEs did not differ significantly: 18 (14.8%) versus 13 (10.8%) in DAV132 versus No-DAV132 patients (difference 3.9%; 95% CI: -4.7 to 12.6). Day 4 FQ plasma levels were unaffected. DAV132 was associated with a >98% reduction in faecal FQ levels (Day 4 to end of treatment; P < 0.001), less impaired microbiota diversity (Shannon index; P = 0.003), increased ex vivo resistance to C. difficile colonization (P = 0.0003) and less frequent FQ-induced VRE acquisition (P = 0.01). Conclusions In FQ-treated hospitalized patients, DAV132 was well tolerated, and FQ plasma concentrations unaffected. DAV132 preserved intestinal microbiota diversity and C. difficile colonization resistance.

Published
2022

7. An open randomized multicentre Phase 2 trial to assess the safety of DAV132 and its efficacy to protect gut microbiota diversity in hospitalized patients treated with fluoroquinolones

Author

Vehreschild, Maria J. G. T., primary, Ducher, Annie, additional, Louie, Thomas, additional, Cornely, Oliver A., additional, Feger, Celine, additional, Dane, Aaron, additional, Varastet, Marina, additional, Vitry, Fabien, additional, de Gunzburg, Jean, additional, Andremont, Antoine, additional, Mentré, France, additional, and Wilcox, Mark H., additional

Published
2022
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8. A Phase 3 Randomized Controlled Trial (MICROCARE) to Evaluate the Efficacy of DAV132 in Preventing Clostridioides Difficile Infection in Patients with Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome and Treated with Intensive Chemotherapy

Author

Vehreschild, Maria, primary, van Werkhoven, Cornelis H., additional, Biehl, Lena, additional, Dane, Aaron, additional, de Kraker, Marlieke E.A., additional, Mentré, France, additional, Burdet, Charles, additional, Glupczynski, Gérald, additional, Timbermont, Leen, additional, Pfender, Elodie, additional, Sablier-Gallis, Frédérique, additional, Andremont, Antoine, additional, de Gunzburg, Jean, additional, Buffet, Renaud, additional, Wilcox, Mark, additional, Cornely, Oliver, additional, Bonten, Marc, additional, and Vitry, Fabien, additional

Published
2021
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16. Genome-edited, donor-derived allogeneic anti-CD19 chimeric antigen receptor T cells in paediatric and adult B-cell acute lymphoblastic leukaemia: results of two phase 1 studies

Author

Benjamin, Reuben, primary, Graham, Charlotte, additional, Yallop, Deborah, additional, Jozwik, Agnieszka, additional, Mirci-Danicar, Oana C, additional, Lucchini, Giovanna, additional, Pinner, Danielle, additional, Jain, Nitin, additional, Kantarjian, Hagop, additional, Boissel, Nicolas, additional, Maus, Marcela V, additional, Frigault, Matthew J, additional, Baruchel, André, additional, Mohty, Mohamad, additional, Gianella-Borradori, Athos, additional, Binlich, Florence, additional, Balandraud, Svetlana, additional, Vitry, Fabien, additional, Thomas, Elisabeth, additional, Philippe, Anne, additional, Fouliard, Sylvain, additional, Dupouy, Sandra, additional, Marchiq, Ibtissam, additional, Almena-Carrasco, Maria, additional, Ferry, Nicolas, additional, Arnould, Sylvain, additional, Konto, Cyril, additional, Veys, Paul, additional, Qasim, Waseem, additional, Benjamin, Reuben, additional, Pagliuca, Antonio, additional, Mufti, Ghulam, additional, Patten, Piers, additional, Kassam, Shireen, additional, Devereux, Stephen, additional, Kazmi, Majid, additional, Cuthill, Kirsty, additional, Potter, Victoria, additional, Kuhnl, Andrea, additional, Metaxa, Victoria, additional, Bonganay, Laarni, additional, Stewart, Orla, additional, Ellard, Rose, additional, Catt, Lorraine, additional, Lewis, Jen, additional, Farzaneh, Farzin, additional, Chappell, Jackie, additional, Mason, Alice, additional, Chu, Vicky, additional, Dunlop, Alan, additional, Saleem, Adeel, additional, Cheung, Gary, additional, Munro, Helena, additional, Giemza, Elka, additional, Ciocarlie, Oana, additional, Chu, Jan, additional, Amrolia, Persis, additional, Rao, Kanchan, additional, Chiesa, Robert, additional, Silva, Juliana, additional, Hill, Annette, additional, Finch, Maria, additional, Young, Lindsey, additional, Hara, Harvinder, additional, Samarasinghe, Sujith, additional, Rao, Anupama, additional, Vora, Ajay, additional, Gilmour, Kimberley, additional, Rivat, Christine, additional, Murphy, Clare, additional, Ahsan, Gulrukh, additional, Said Shamsah, Rasha, additional, James, Jesmina, additional, Inglott, Sarah, additional, Wright, Gary, additional, Adams, Stuart, additional, Izotova, Natalia, additional, Konopleva, Marina, additional, Wierda, William, additional, Jabbour, Elias, additional, Kebrieai, Partow, additional, Jones, Emily, additional, McGee, Kara, additional, Maus, Marcela, additional, Frigault, Matthew, additional, Brown, Jami, additional, Toncheva, Vesselina, additional, Casey, Keagan, additional, Hock, Hanno, additional, McKeown, Meaghan A, additional, Mathews, Richard, additional, Spitzer, Thomas, additional, Raffoux, Emmanuel, additional, Lengliné, Etienne, additional, Itzykson, Raphael, additional, Rabian, Florence, additional, Larghero, Jérôme, additional, Madelaine, Isabelle, additional, Azoulay, Elie, additional, Clappier, Emmanuelle, additional, Caillat-Zucman, Sophie, additional, Meunier, Martine, additional, Celli-Lebras, Karine, additional, Tremorin, Marie-Thérèse, additional, Yakouben, Karima, additional, Mechinaud-Heloury, Françoise, additional, Grain, Audrey, additional, Alimi, Aurélia, additional, Roupret, Julie, additional, Chaillou, Delphine, additional, Cavé, Hélène, additional, Caye-Eude, Aurelie, additional, Fenneteau, Odile, additional, Lainey, Elodie, additional, Naudin, Jerome, additional, Brissot, Eolia, additional, Dulery, Remy, additional, Malard, Florent, additional, Mediavilla, Clémence, additional, Bonnin, Agnès, additional, Vekhoff, Anne, additional, Ledraa, Tounes, additional, and Daguenel-Nguyen, Anne, additional

Published
2020
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17. open randomized multicentre Phase 2 trial to assess the safety of DAV132 and its efficacy to protect gut microbiota diversity in hospitalized patients treated with fluoroquinolones.

Author

Vehreschild, Maria J. G. T., Ducher, Annie, Louie, Thomas, Cornely, Oliver A., Feger, Celine, Dane, Aaron, Varastet, Marina, Vitry, Fabien, Gunzburg, Jean de, Andremont, Antoine, Mentré, France, and Wilcox, Mark H.

Abstract

Background DAV132 (colon-targeted adsorbent) has prevented antibiotic-induced effects on microbiota in healthy volunteers. Objectives To assess DAV132 safety and biological efficacy in patients. Patients and methods An open-label, randomized [stratification: fluoroquinolone (FQ) indication] multicentre trial comparing DAV132 (7.5 g, 3 times a day, orally) with No-DAV132 in hospitalized patients requiring 5–21 day treatment with FQs and at risk of Clostridioides difficile infection (CDI). FQ and DAV132 were started simultaneously, DAV132 was administered for 48 h more, and patients were followed up for 51 days. The primary endpoint was the rate of adverse events (AEs) independently adjudicated as related to DAV132 and/or FQ. The planned sample size of 260 patients would provide a 95% CI of ±11.4%, assuming a 33% treatment-related AE rate. Plasma and faecal FQ concentrations, intestinal microbiota diversity, intestinal colonization with C. difficile , MDR bacteria and yeasts, and ex vivo resistance to C. difficile faecal colonization were assessed. Results Two hundred and forty-three patients (median age 71 years; 96% with chronic comorbidity) were included (No-DAV132, n = 120; DAV132, n = 123). DAV132- and/or FQ-related AEs did not differ significantly: 18 (14.8%) versus 13 (10.8%) in DAV132 versus No-DAV132 patients (difference 3.9%; 95% CI: −4.7 to 12.6). Day 4 FQ plasma levels were unaffected. DAV132 was associated with a >98% reduction in faecal FQ levels (Day 4 to end of treatment; P < 0.001), less impaired microbiota diversity (Shannon index; P = 0.003), increased ex vivo resistance to C. difficile colonization (P = 0.0003) and less frequent FQ-induced VRE acquisition (P = 0.01). Conclusions In FQ-treated hospitalized patients, DAV132 was well tolerated, and FQ plasma concentrations unaffected. DAV132 preserved intestinal microbiota diversity and C. difficile colonization resistance. [ABSTRACT FROM AUTHOR]

Published
2022
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20. The Role of Circumstances of Diagnosis and Access to Dermatological Care in Early Diagnosis of Cutaneous Melanoma: A Population-Based Study in France

Author

Durbec, Frédérique, Vitry, Fabien, Granel-Brocard, Florence, Lipsker, Dan, Aubin, François, Hédelin, Guy, Dalac, Sophie, Truchetet, François, Michel, Catherine, Batard, Marie-Laure, Domissy-Baury, Beatrice, Halna, Jean-Michel, Schmutz, Jean Luc, Delvincourt, Christian, Reuter, Georges, Dalle, Stéphane, Bernard, Philippe, Danzon, Arlette, and Grange, Florent

Published
2010

32. Variations in management of stage to stage III cutaneous melanoma: a population-based study of clinical practices in France

Author

Grange, Florent, Vitry, Fabien, Granel-Brocard, Florence, Lipsker, Dan, Aubin, Francois, Hedelin, Guy, Dalac, Sophie, Truchetet, Francois, Michel, Catherine, Batard, Marie-Laure, Baury, Beatrice, Halna, Jean-Michel, Schmutz, Jean Luc, Delvincourt, Christian, Reuter, Georges, Dalle, Stephane, Bernard, Phillipe, and Danzon, Arlette

Subjects
Melanoma -- Diagnosis, Melanoma -- Care and treatment, Skin cancer -- Diagnosis, Skin cancer -- Care and treatment, Health
Published
2008

34. Does the availability of positron emission tomography modify diagnostic strategies for solitary pulmonary nodules? An observational study in France

Author

Arveux Patrick, Alzahouri Kazem, Jay Nicolas, Baumann Cédric, Lemonnier Irawati, Jolly Damien, Lejeune Catherine, Velten Michel, Vitry Fabien, Woronoff-Lemsi Marie-Christine, and Guillemin Francis

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background Previous studies showed that at the individual level, positron emission tomography (PET) has some benefits for patients and physicians in terms of cancer management and staging. We aimed to describe the benefits of (PET) in the management of solitary pulmonary nodules (SPNs) in a population level, in terms of the number of diagnostic and invasive tests performed, time to diagnosis and factors determining PET utilization. Methods In an observational study, we examined reports of computed tomography (CT) performed and mentioning "spherical lesion", "nodule" or synonymous terms. We found 11,515 reports in a before-PET period, 2002–2003, and 20,075 in an after-PET period, 2004–2005. Patients were followed through their physician, who was responsible for diagnostic management. Results We had complete data for 112 patients (73.7%) with new cases of SPN in the before-PET period and 250 (81.4%) in the after-PET period. Patients did not differ in mean age (64.9 vs. 64.8 years). The before-PET patients underwent a mean of 4 tests as compared with 3 tests for the after-PET patients (p = 0.08). Patients in the before-PET period had to wait 41.4 days, on average, before receiving a diagnosis as compared with 24.0 days, on average, for patients in the after-PET period who did not undergo PET (p < 0.001). In the after-PET period, 11% of patients underwent PET during the diagnostic process. A spiculated nodule was more likely to determine prescription for PET (p < 0.001). Multivariate analysis revealed that patients in both periods underwent fewer tests when PET was prescribed by general practitioners (p < 0.001) and if the nodule was not spiculated (p < 0.001). The proportion of unnecessary invasive approaches prescribed (47% vs. 49%) did not differ between the groups. Conclusion In our study, 1 year after the availability of PET, the technology was not the first choice for diagnostic management of SPN. Even though we observed a tendency for reduced number of tests and mean time to diagnosis with PET, these phenomena did not fully relate to PET availability in health communities. In addition, the availability of PET in the management of SPN diagnosis did not reduce the overall rate of unnecessary invasive approaches.

Published
2009
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35. Bronchial epithelial spheroids: an alternative culture model to investigate epithelium inflammation-mediated COPD

Author

Gangloff Sophie C, Boxio Rachel, Vitry Fabien, Al Alam Denise, Perotin Jeanne M, Dury Sandra, Deslee Gaetan, Guenounou Moncef, Lebargy François, and Belaaouaj Abderrazzaq

Subjects
Diseases of the respiratory system, RC705-779
Abstract

Abstract Background Chronic obstructive pulmonary disease (COPD) is characterized by abnormal lung inflammation that exceeds the protective response. Various culture models using epithelial cell lines or primary cells have been used to investigate the contribution of bronchial epithelium in the exaggerated inflammation of COPD. However, these models do not mimic in vivo situations for several reasons (e.g, transformed epithelial cells, protease-mediated dissociation of primary cells, etc.). To circumvent these concerns, we developed a new epithelial cell culture model. Methods Using non transformed non dissociated bronchial epithelium obtained by bronchial brushings from COPD and non-COPD smokers, we developed a 3-dimensional culture model, bronchial epithelial spheroids (BES). BES were analyzed by videomicroscopy, light microscopy, immunofluorescence, and transmission electron microscopy. We also compared the inflammatory responses of COPD and non-COPD BES. In our study, we chose to stimulate BES with lipopolycaccharide (LPS) and measured the release of the pro-inflammatory mediators interleukin-8 (IL-8) and leukotriene B4 (LTB4) and the anti-inflammatory mediator prostaglandin E2 (PGE2). Results BES obtained from both COPD and non-COPD patients were characterized by a polarized bronchial epithelium with tight junctions and ciliary beating, composed of basal cells, secretory cells and ciliated cells. The ciliary beat frequency of ciliated cells was not significantly different between the two groups. Of interest, BES retained their characteristic features in culture up to 8 days. BES released the inflammatory mediators IL-8, PGE2 and LTB4 constitutively and following exposure to LPS. Interestingly, LPS induced a higher release of IL-8, but not PGE2 and LTB4 in COPD BES (p < 0.001) which correlated with lung function changes. Conclusion This study provides for the first time a compelling evidence that the BES model provides an unaltered bronchial surface epithelium. More importantly, BES represent an attractive culture model to investigate the mechanisms of injuring agents that mediate epithelial cell inflammation and its contribution to COPD pathogenesis.

Published
2007
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38. Does the availability of positron emission tomography modify diagnostic strategies for solitary pulmonary nodules? An observational study in France

Author

Lemonnier, Irawati, primary, Baumann, Cédric, additional, Jay, Nicolas, additional, Alzahouri, Kazem, additional, Arveux, Patrick, additional, Jolly, Damien, additional, Lejeune, Catherine, additional, Velten, Michel, additional, Vitry, Fabien, additional, Woronoff-Lemsi, Marie-Christine, additional, and Guillemin, Francis, additional

Published
2009
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43. M1018a The Efficacy of Prefixed Equimolar Nitrous Oxyde and Oxygen Mixture (N2o) for Gastroduodenal Endoscopy Tolerance: A Randomized, Double-Blind Trial, Versus Placebo

Author

Bernard-Chabert, Brigitte, primary, Papon, Benjamin, additional, Vitry, Fabien, additional, Scaglia, Elodie, additional, Brixi-Benmansour, Hedia, additional, Heurgué, Alexandra, additional, Lagarde, Stephanie, additional, Ramaholimihaso, Fidy, additional, Bouché, Olivier, additional, Cadiot, Guillaume, additional, and Thiefin, Gerard, additional

Published
2008
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45. Comparison of operator radiation exposure with optimized radiation protection devices during coronary angiograms and ad hoc percutaneous coronary interventions by radial and femoral routes

Author

Brasselet, Camille, primary, Blanpain, Thierry, additional, Tassan-Mangina, Sophie, additional, Deschildre, Alain, additional, Duval, Sébastien, additional, Vitry, Fabien, additional, Gaillot-Petit, Nathalie, additional, Clément, Jean Paul, additional, and Metz, Damien, additional

Published
2007
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49. Réflexions préliminaires à l'utilisation de l'HemoCue® en hémodialyse.

Author

Montagnac, Richard, Vitry, Fabien, Rehn, Yves, Cottey, Monique, and Schillinger, Francis

Subjects
HEMOGLOBINS, BLOOD pigments, ERYTHROPOIETIN, PULMONARY veins
Abstract

Copyright of Néphrologie & Thérapeutique is the property of John Libbey Eurotext Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2007
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50. Thiopurine S-methyltransferase genotypic analysis in autoimmune bullous diseases.

Author

Bezier M, Reguiai Z, Vitry F, Broly F, and Bernard P

Subjects
Adult, Aged, Aged, 80 and over, Autoimmune Diseases enzymology, Female, Genotype, Humans, Male, Middle Aged, Retrospective Studies, Skin Diseases, Vesiculobullous enzymology, Autoimmune Diseases genetics, Methyltransferases genetics, Skin Diseases, Vesiculobullous genetics
Abstract

Thiopurine S-methyltransferase (TPMT) activity is inversely related to the risk of developing severe hematopoietic toxicity in patients treated with azathioprine. The aim of this study was to evaluate the usefulness of TPMT genotyping in severe cases of autoimmune bullous diseases treated with azathioprine. A retrospective study of TPMT genotyping was performed in patients with autoimmune bullous diseases hospitalized in a single centre between 1999 and 2006 and susceptible of being treated by azathioprine. Among 75 patients tested, 70 (93%) had a high TPMT activity and 5 (7%) an intermediate activity. TPMT genotyping was performed in 33/34 patients currently treated with azathioprine. Haematopoietic side-effects (usually moderate) were observed in 12/34 patients treated with a mean dosage of 2.7 mg/kg/day and occurred, despite a high predicted TPMT activity. No myelotoxicity was observed in the two patients with intermediate predicted TPMT activity (mean dosage: 1.7 mg/kg/day), who obtained a clinically complete remission. Although strongly recommended before azathioprine treatment, predicting TPMT activity appears only marginally helpful in patients with autoimmune bullous diseases, mainly for adjusting the azathioprine dosage. In addition, a normal TPMT genotyping is not a guarantee against the occurrence of haematological side-effects.

Published
2008
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