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1. Clinical safety and efficacy of novel antifungal, fosmanogepix, for the treatment of candidaemia: results from a Phase 2 trial.

Author

Pappas, Peter, Vazquez, Jose, Oren, Ilana, Rahav, Galia, Aoun, Mickael, Bulpa, Pierre, Ben-Ami, Ronen, Ferrer, Ricard, Mccarty, Todd, Schlamm, Haran, Bien, Paul, Barbat, Sara, Wedel, Pamela, Oborska, Iwona, Tawadrous, Margaret, Hodges, Michael, and Thompson, George

Subjects
Adult, Humans, Antifungal Agents, Candidemia, Fungi, Candida, Treatment Outcome
Abstract

BACKGROUND: Fosmanogepix is a first-in-class antifungal targeting the fungal enzyme Gwt1, with broad-spectrum activity against yeasts and moulds, including multidrug-resistant fungi, formulated for intravenous (IV) and oral administration. METHODS: This global, multicenter, non-comparative study evaluated the safety and efficacy of fosmanogepix for first-line treatment of candidaemia in non-neutropenic adults. Participants with candidaemia, defined as a positive blood culture for Candida spp. within 96 h prior to study entry, with ≤2 days of prior systemic antifungals, were eligible. Participants received fosmanogepix for 14 days: 1000 mg IV twice daily on Day 1, followed by maintenance 600 mg IV once daily, and optional switch to 700 mg orally once daily from Day 4. Eligible participants who received at least one dose of fosmanogepix and had confirmed diagnosis of candidaemia (

Published
2023

2. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis

Author

Acar, Kadir, Afanasyev, Boris, Alonso Alonso, Aránzazu, Anttila, Veli-Jukka, Barba Suñol, Pere, Blesing, Norbert, Comeau, Terrance, del Campo, Teresa, Disperati, Patricia, Eek, Richard, Eom, HyeonSeok, Gaidano, Gianluca, Grosicki, Sebastian, Guillaume, Thierry, Homenda, Wojciech, Hwang, William, Ilyin, Nikolay, Johnston, Anna, Kim, Seok Jin, Kuo, Ching-Yuan, Kuvshinov, Aleksey, Lee, Dong-Gun, Lee, Jae Hoon, Lee, Je-Jung, Lepretre, Stephane, Lie, Albert Kwok-Wai, Lucchesi, Alessandro, Masood, Ahmed, Mir, Naheed, Miranda Castillo, Anna Carolina, Mullane, Kathleen, Myasnikov, Alexandr, Oña Navarrete, Raquel, Pauksens, Karlis, Peniket, Andrew, Perez de Oteyza, Jaime, Pohlreich, David, Pullon, Humphrey, Quittet, Philippe, Rodon, Philippe, Rombo, Lars, Samoylova, Olga, Sanmartin Berglund, Johan, Schattner, Ariah, Selleslag, Dominik, Sinisalo, Marjatta, Sultan, Faisal, Theunissen, Koen, Turner, Paul, Wang, Po-Nan, Yáñez San Segundo, Lucrecia, Young, Jo-Anne, Zachee, Pierre, Zaja, Francesco, Dagnew, Alemnew F, Ilhan, Osman, Lee, Won-Sik, Woszczyk, Dariusz, Kwak, Jae-Yong, Bowcock, Stella, Sohn, Sang Kyun, Rodriguez Macías, Gabriela, Chiou, Tzeon-Jye, Quiel, Dimas, Aoun, Mickael, Navarro Matilla, Maria Belen, de la Serna, Javier, Milliken, Samuel, Murphy, John, McNeil, Shelly A, Salaun, Bruno, Di Paolo, Emmanuel, Campora, Laura, López-Fauqued, Marta, El Idrissi, Mohamed, Schuind, Anne, Heineman, Thomas C, Van den Steen, Peter, and Oostvogels, Lidia

Published
2019
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3. Empiric vs Preemptive Antifungal Strategy in High-Risk Neutropenic Patients on Fluconazole Prophylaxis: A Randomized Trial of the European Organization for Research and Treatment of Cancer

Author

Maertens, Johan, Lodewyck, Tom, Donnelly, J Peter, Chantepie, Sylvain, Robin, Christine, Blijlevens, Nicole, Turlure, Pascal, Selleslag, Dominik, Baron, Frederic, Aoun, Mickael, Heinz, Werner J, Bertz, Hartmut, Racil, Zdenek, Vandercam, Bernard, Drgona, Lubos, Coiteux, Valerie, Llorente, Cristina Castilla, Schaefer-Prokop, Cornelia, Paesmans, Marianne, Ameye, Lieveke, Meert, Liv, Cheung, Kin Jip, Hepler, Deborah A, Loeffler, Juergen, Barnes, Rosemary, Marchetti, Oscar, Verweij, Paul, Lamoth, Frederic, Bochud, Pierre-Yves, Schwarzinger, Michael, and Cordonnier, Catherine

Subjects
Microbiology (medical), empiric, Science & Technology, Immunology, lnfectious Diseases and Global Health Radboud Institute for Molecular Life Sciences [Radboudumc 4], FEBRILE, STEM-CELL TRANSPLANTS, Microbiology, THERAPY, PERSISTENT FEVER, preemptive, CIRCULATING GALACTOMANNAN, All institutes and research themes of the Radboud University Medical Center, Infectious Diseases, galactomannan, neutropenia, COMPUTED-TOMOGRAPHY, INVASIVE FUNGAL-INFECTION, LIPOSOMAL AMPHOTERICIN-B, ASPERGILLOSIS, Life Sciences & Biomedicine, HEMATOLOGY PATIENTS, antifungal, Rare cancers Radboud Institute for Health Sciences [Radboudumc 9]
Abstract

Background Empiric antifungal therapy is considered the standard of care for high-risk neutropenic patients with persistent fever. The impact of a preemptive, diagnostic-driven approach based on galactomannan screening and chest computed tomography scan on demand on survival and on the risk of invasive fungal disease (IFD) during the first weeks of high-risk neutropenia is unknown. Methods Patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and allogeneic hematopoietic cell transplant recipients were randomly assigned to receive caspofungin empirically (arm A) or preemptively (arm B), while receiving fluconazole 400 mg daily prophylactically. The primary end point of this noninferiority study was overall survival (OS) 42 days after randomization. Results Of 556 patients recruited, 549 were eligible: 275 in arm A and 274 in arm B. Eighty percent of the patients had AML or MDS requiring high-dose chemotherapy, and 93% of them were in the first induction phase. At day 42, the OS was not inferior in arm B (96.7%; 95% confidence interval [CI], 93.8%–98.3%) when compared with arm A (93.1%; 95% CI, 89.3%–95.5%). The rates of IFDs at day 84 were not significantly different, 7.7% (95% CI, 4.5%–10.8%) in arm B vs 6.6% (95% CI, 3.6%–9.5%) in arm A. The rate of patients who received caspofungin was significantly lower in arm B (27%) than in arm A (63%; P < .001). Conclusions The preemptive antifungal strategy was safe for high-risk neutropenic patients given fluconazole as prophylaxis, halving the number of patients receiving antifungals without excess mortality or IFDs. Clinical Trials Registration. NCT01288378; EudraCT 2010-020814-27.

Published
2022

4. Isavuconazole versus voriconazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentous fungi (SECURE): a phase 3, randomised-controlled, non-inferiority trial

Author

Maertens, Johan A, Raad, Issam I, Marr, Kieren A, Patterson, Thomas F, Kontoyiannis, Dimitrios P, Cornely, Oliver A, Bow, Eric J, Rahav, Galia, Neofytos, Dionysios, Aoun, Mickael, Baddley, John W, Giladi, Michael, Heinz, Werner J, Herbrecht, Raoul, Hope, William, Karthaus, Meinolf, Lee, Dong-Gun, Lortholary, Olivier, Morrison, Vicki A, Oren, Ilana, Selleslag, Dominik, Shoham, Shmuel, Thompson, George R, III, Lee, Misun, Maher, Rochelle M, Schmitt-Hoffmann, Anne-Hortense, Zeiher, Bernhardt, and Ullmann, Andrew J

Published
2016
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6. Empiric vs Preemptive Antifungal Strategy in High-Risk Neutropenic Patients on Fluconazole Prophylaxis: A Randomized Trial of the European Organization for Research and Treatment of Cancer.

Author

Maertens, Johan, Lodewyck, Tom, Donnelly, J Peter, Chantepie, Sylvain, Robin, Christine, Blijlevens, Nicole, Turlure, Pascal, Selleslag, Dominik, Baron, Frédéric, Aoun, Mickael, Heinz, Werner J, Bertz, Hartmut, Ráčil, Zdeněk, Vandercam, Bernard, Drgona, Lubos, Coiteux, Valerie, Llorente, Cristina Castilla, Schaefer-Prokop, Cornelia, Paesmans, Marianne, and Ameye, Lieveke

Subjects
MYELODYSPLASTIC syndromes, ANTIFUNGAL agents, CLINICAL trials, CONFIDENCE intervals, CHEST X rays, CASPOFUNGIN, CANCER chemotherapy, NEUTROPENIA, PATIENTS, MEDICAL screening, RISK assessment, RANDOMIZED controlled trials, SURVIVAL analysis (Biometry), DESCRIPTIVE statistics, RESEARCH funding, MYCOSES, FLUCONAZOLE, HEMATOPOIETIC stem cell transplantation, STATISTICAL sampling, COMPUTED tomography, CHEMOPREVENTION, TRANSPLANTATION of organs, tissues, etc., PATIENT safety, DISEASE risk factors
Abstract

Background Empiric antifungal therapy is considered the standard of care for high-risk neutropenic patients with persistent fever. The impact of a preemptive, diagnostic-driven approach based on galactomannan screening and chest computed tomography scan on demand on survival and on the risk of invasive fungal disease (IFD) during the first weeks of high-risk neutropenia is unknown. Methods Patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and allogeneic hematopoietic cell transplant recipients were randomly assigned to receive caspofungin empirically (arm A) or preemptively (arm B), while receiving fluconazole 400 mg daily prophylactically. The primary end point of this noninferiority study was overall survival (OS) 42 days after randomization. Results Of 556 patients recruited, 549 were eligible: 275 in arm A and 274 in arm B. Eighty percent of the patients had AML or MDS requiring high-dose chemotherapy, and 93% of them were in the first induction phase. At day 42, the OS was not inferior in arm B (96.7%; 95% confidence interval [CI], 93.8%–98.3%) when compared with arm A (93.1%; 95% CI, 89.3%–95.5%). The rates of IFDs at day 84 were not significantly different, 7.7% (95% CI, 4.5%–10.8%) in arm B vs 6.6% (95% CI, 3.6%–9.5%) in arm A. The rate of patients who received caspofungin was significantly lower in arm B (27%) than in arm A (63%; P <.001). Conclusions The preemptive antifungal strategy was safe for high-risk neutropenic patients given fluconazole as prophylaxis, halving the number of patients receiving antifungals without excess mortality or IFDs. Clinical Trials Registration. NCT01288378; EudraCT 2010-020814-27. [ABSTRACT FROM AUTHOR]

Published
2023
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10. Point prevalence survey of antimicrobial use and healthcare-associated infections in Belgian acute care hospitals : results of the Global-PPS and ECDC-PPS 2017

Author

Vandael, Eline, Latour, Katrien, Goossens, Herman, Magerman, Koen, Drapier, Nico, Catry, Boudewijn, Versporten, Ann, Andre, Marie, Aouachria, Samy, Aoun, Mickael, Bafort, Kristof, Bartholomeus, Sofie, Blumental, Sophie, Bothy, Anais, Brands, Christiane, Brassinne, Laetitia, Briquet, Caroline, Cartuyvels, Reinoud, Ceyssens, Clara, Cooreman, Sarah, Decleire, Pierre-Yves, Declercq, Philippe, De Cooman, Liesbeth, De Cuyper, Inge, Degraeve, Dirk, Delaere, Benedicte, Delvallee, Melanie, Desmedt, Marjoleine, Diaz, Victoria, Dragos, Ilisei, Dugernier, Thierry, Elsen, Elodie, Filippin, Lorenzo, Firre, Eric, Frans, Johan, Gabriels, Patrick, Gadisseux, Philippe, Gerard, Michele, Glibert, Bart, Goegebuer, Truus, Gonissen, Viviane, Harrouk, Antoine, Holemans, Xavier, Honore, Aline, Ide, Louis, Jansens, Hilde, Kidd, Francois, Koch, Annelies, Konopnicki, Deborah, Lefevre, Philippe, Lespagnard, Marc, Lorent, Sophie, Maillart, Evelyne, Mallet, Martine, Markowicz, Samuel, Mathieu, Delphine, Michel, Philippe, Noirhomme, Severine, Papin, Pauline, Piette, Anne, Pollet, Leen, Rossi, Camelia, Schatt, Patricia, Sermijn, Erica, Sterckx, Astrid, Steyaert, Sophia, Swinnen, Walter, Teixeira Lopes, Liliana, Thoelen, Inge, Turkova, Myriam, Van den Abeele, Anne-Marie, Van den Berg, Valerie, Van der beek, Danielle, Vanderper, Vanessa, Vandevelde, Marc, Vandewal, Wouter, Van Herendael, Bruno, Vanheule, Geert, Van Hoecke, Frederik, Van Kerkhoven, Dana, Van Liedekerke, Ann, Vanneste, Lorenz, Vekemans, Marc, Vercheval, Christelle, Verhamme, Katia, Verniest, Thessa, Westerlinck, Veerle, Wybo, Ingrid, Belgian Point Prevalence Survey, Swinnen, Walter/0000-0001-5387-149X, and Vriendenkring VUB

Subjects
Male, Antibiotics, Drug resistance, Antimicrobial Stewardship, Medical microbiology, Drug Utilization Review, Belgium, Risk Factors, Acute care, Antimicrobial consumption, Prevalence, Medicine, Pharmacology (medical), Pharmacology & Pharmacy, Point prevalence survey, Child, health care economics and organizations, Public, Environmental & Occupational Health, Medicine(all), Aged, 80 and over, Cross Infection, Pharmacology. Therapy, Middle Aged, Antimicrobial, Anti-Bacterial Agents, Infectious Diseases, Child, Preschool, Female, Life Sciences & Biomedicine, Microbiology (medical), Adult, medicine.medical_specialty, Adolescent, medicine.drug_class, education, Healthcare-associated infections, Microbiology, lcsh:Infectious and parasitic diseases, Young Adult, Internal medicine, Humans, lcsh:RC109-216, Medical prescription, Biology, Aged, Science & Technology, business.industry, Research, Public Health, Environmental and Occupational Health, Infant, Newborn, Infant, Généralités, medicine.disease, Health Surveys, Confidence interval, Pneumonia, Acute care hospitals, Human medicine, business
Abstract

Background: The point prevalence survey of healthcare-associated infections (HAIs) and antimicrobial use organized by the European Centre for Disease Prevention and Control (ECDC-PPS) and the Global Point Prevalence Survey of antimicrobial consumption (Global-PPS) were simultaneously performed in Belgian acute care hospitals in 2017. Methods: Belgian acute care hospitals were invited to participate in either the ECDC or Global-PPS. Hospital/ward/patient-level data were collected between September-December 2017. All patients present in the wards at 8 a.m. on the day of the PPS were included. The data of the ECDC and Global-PPS on antimicrobial consumption were pooled. Detailed data on HAIs were analysed for ECDC-PPS. Results: Overall, 110 Belgian acute care hospital sites participated in the ECDC and Global-PPS (countrywide participation rate: 81.4%, 28,007 patients). Overall, a crude prevalence of patients with at least one antimicrobial of 27.1% (95% confidence interval (CI) 26.5-27.6%) was found. The most frequently reported indications were pneumonia (23.2%), urinary tract infections (15.2%) and skin and soft tissue infections (11.9%). The reason for antimicrobial use was recorded for 81.9% of the prescriptions, a stop/review date for 40.8% and compliance with local antibiotic guidelines for 76.6%. In the ECDC-PPS, the crude prevalence of patients with at least one HAI was 7.3% (95%CI 6.8-7.7%). Most frequently reported HAIs were pneumonia (21.6%) and urinary tract infections (21.3%). Conclusions: HAI and antimicrobial use prevalence remained stable in comparison with the previous PPS (7.1% and 27.4% in 2011 and 2015, respectively). Belgian hospitals should be further stimulated to set local targets to improve antibiotic prescribing and reduce HAI., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2020

12. Liposomal amphotericin B as initial therapy for invasive mold infection: a randomized trial comparing a high-loading dose regimen with standard dosing (AmBiLoad Trial)

Author

Cornely, Oliver A., Maertens, Johan, Bresnik, Mark, Ebrahimi, Ramin, Ullmann, Andrew J., Bouza, Emilio, Heussel, Claus Peter, Lortholary, Olivier, Rieger, Christina, Boehme, Angelika, Aoun, Mickael, Horst, Heinz-August, Thiebaut, Anne, Ruhnke, Markus, Reichert, Dietmar, Vianelli, Nicola, Krause, Stefan W., Olavarria, Eduardo, and Herbrecht, Raoul

Subjects
Amphotericin B -- Dosage and administration, Amphotericin B -- Research, Aspergillosis -- Care and treatment, Health, Health care industry
Published
2007

13. A randomized, blinded, multicenter trial of lipid-associated amphotericin B alone versus in combination with an antibody-based inhibitor of heat shock protein 90 in patients with invasive candidiasis

Author

Pachl, Jan, Svoboda, Petr, Jacobs, Frederique, Vandewoude, Koenraad, van der Hoven, Ben, Spronk, Peter, Masterson, Gary, Malbrain, Manu, Aoun, Mickael, Garbino, Jorge, Takala, Jukka, Drgona, Lubos, Burnie, James, and Matthews, Ruth

Subjects
Amphotericin B -- Analysis, Heat shock proteins -- Analysis, Candidiasis -- Research, Candidiasis -- Physiological aspects, Candidiasis -- Care and treatment, Health, Health care industry
Published
2006

15. Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation A Randomized Clinical Trial

Author

Bastidas, Adriana de la Serna, Javier El Idrissi, Mohamed and Oostvogels, Lidia Quittet, Philippe Lopez-Jimenez, Javier and Vural, Filiz Pohlreich, David Zuckerman, Tsila Issa, Nicolas C. Gaidano, Gianluca Lee, Je-Jung Abhyankar, Sunil and Solano, Carlos Perez de Oteyza, Jaime Satlin, Michael J. and Schwartz, Stefan Campins, Magda Rocci, Alberto Llamas, Carlos Vallejo Lee, Dong-Gun Tan, Sen Mui Johnston, Anna M. and Grigg, Andrew Boeckh, Michael J. Campora, Laura and Lopez-Fauqued, Marta Heineman, Thomas C. Stadtmauer, Edward A. and Sullivan, Keith M. Alonso Alonso, Aranzazu Anagnostopoulos, Achilles Andreadis, Charalambos (Babis) Angelopoulou, Maria and Anttila, Veli-Jukka Aoun, Mickael Barista, Ibrahim Berkahn, Leanne Bloor, Adrian J. C. Broady, Raewyn Brossart, Peter and Buadi, Francis K. Bulabois, Claude-Eric Cantin, Guy and Cellini, Claudia Chandrasekar, Pranatharthi Haran Chauncey, Thomas Cuneo, Antonio Dadwal, Sanjeet Singh Dickinson, Michael Eom, HyeonSeok Esquirol Sanfeliu, Albert Ferra Coll, Christelle Flomenberg, Phyllis R. Pilar Gonzalez-Rodriguez, Ana and Gottlieb, David J. Grisariu, Sigal Guenther, Andreas and Gutman, Jonathan Hahn, Uwe Heinz, Werner J. Heras, Inmaculada Ikeda, Takashi Jarque, Isidro Karthaus, Meinolf and Kerre, Tessa Kiani, Alexander Klein, Andreas K. Kofla, Grzegorz Kryuchkova, Irina V. Kuo, Ching-Yuan Kuruvilla, John Kuvshinov, Aleksey Kwak, Jae-Yong Lee, Jae Hoon and Lepretre, Stephane Lie, Albert Kwok-Wai Lucchesi, Alessandro and Maertens, Johan Marijt, Erik W. A. Martinez Munoz, Carmen and Michieli, Mariagrazia Milliken, Samuel T. Milpied, Noel and Monserrat Coll, Jorge Mossad, Sherif Beniameen Murphy, John and Navarro Matilla, Maria Belen Novak, Jan Olney, Harold J. Ona Navarrete, Raquel Pascual Cascon, Maria Jesus Peniket, Andy and Penka, Ganeva Piatkowska-Jakubas, Beata Polo Zarzuela, Marta and Quiel, Dimas Rowley, Scott D. Sabry, Waleed Salmi, Tommi Mikael Selleslag, Dominik L. D. Shea, Thomas C. Silling, Gerda Sinisalo, Ulla Marjatta Sohn, Sang Kyun Staib, Peter and Szer, Jeff Theunissen, Koen Topcuoglu, Pervin Tyurina, Natalya G. Uvarov, Mikhail Wahid, Fadilah S. Abdul Yanez San Segundo, Lucrecia Yegin, Zeynep Arzu Yeh, Su-Peng Yip, Sze-Fai Yoon, Sung Soo Young, Jo-Anne H. Zachee, Pierre and Zaja, Francesco ZOE-HSCT Study Grp Collaborators

Abstract

IMPORTANCE Herpes zoster, a frequent complication following autologous hematopoietic stem cell transplantation (HSCT), is associated with significant morbidity. A nonlive adjuvanted recombinant zoster vaccine has been developed to prevent posttransplantation zoster. OBJECTIVE To assess the efficacy and adverse event profile of the recombinant zoster vaccine in immunocompromised autologous HSCT recipients. DESIGN, SETTING, AND PARTICIPANTS Phase 3, randomized, observer-blinded study conducted in 167 centers in 28 countries between July 13, 2012, and February 1, 2017, among 1846 patients aged 18 years or older who had undergone recent autologous HSCT. INTERVENTIONS Participants were randomized to receive 2 doses of either recombinant zoster vaccine (n=922) or placebo (n=924) administered into the deltoid muscle; the first dose was given 50 to 70 days after transplantation and the second dose 1 to 2 months thereafter. MAIN OUTCOMES AND MEASURES The primary end point was occurrence of confirmed herpes zoster cases. RESULTS Among 1846 autologous HSCT recipients (mean age, 55 years; 688 [37%] women) who received 1 vaccine or placebo dose, 1735 (94%) received a second dose and 1366 (74%) completed the study. During the 21-month median follow-up, at least 1 herpes zoster episode was confirmed in 49 vaccine and 135 placebo recipients (incidence, 30 and 94 per 1000 person-years, respectively), an incidence rate ratio (IRR) of 0.32 (95% CI, 0.22-0.44; P

Published
2019

20. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis

Author

Dagnew, Alemnew F, primary, Ilhan, Osman, additional, Lee, Won-Sik, additional, Woszczyk, Dariusz, additional, Kwak, Jae-Yong, additional, Bowcock, Stella, additional, Sohn, Sang Kyun, additional, Rodriguez Macías, Gabriela, additional, Chiou, Tzeon-Jye, additional, Quiel, Dimas, additional, Aoun, Mickael, additional, Navarro Matilla, Maria Belen, additional, de la Serna, Javier, additional, Milliken, Samuel, additional, Murphy, John, additional, McNeil, Shelly A, additional, Salaun, Bruno, additional, Di Paolo, Emmanuel, additional, Campora, Laura, additional, López-Fauqued, Marta, additional, El Idrissi, Mohamed, additional, Schuind, Anne, additional, Heineman, Thomas C, additional, Van den Steen, Peter, additional, Oostvogels, Lidia, additional, Acar, Kadir, additional, Afanasyev, Boris, additional, Alonso Alonso, Aránzazu, additional, Anttila, Veli-Jukka, additional, Barba Suñol, Pere, additional, Blesing, Norbert, additional, Comeau, Terrance, additional, del Campo, Teresa, additional, Disperati, Patricia, additional, Eek, Richard, additional, Eom, HyeonSeok, additional, Gaidano, Gianluca, additional, Grosicki, Sebastian, additional, Guillaume, Thierry, additional, Homenda, Wojciech, additional, Hwang, William, additional, Ilyin, Nikolay, additional, Johnston, Anna, additional, Kim, Seok Jin, additional, Kuo, Ching-Yuan, additional, Kuvshinov, Aleksey, additional, Lee, Dong-Gun, additional, Lee, Jae Hoon, additional, Lee, Je-Jung, additional, Lepretre, Stephane, additional, Lie, Albert Kwok-Wai, additional, Lucchesi, Alessandro, additional, Masood, Ahmed, additional, Mir, Naheed, additional, Miranda Castillo, Anna Carolina, additional, Mullane, Kathleen, additional, Myasnikov, Alexandr, additional, Oña Navarrete, Raquel, additional, Pauksens, Karlis, additional, Peniket, Andrew, additional, Perez de Oteyza, Jaime, additional, Pohlreich, David, additional, Pullon, Humphrey, additional, Quittet, Philippe, additional, Rodon, Philippe, additional, Rombo, Lars, additional, Samoylova, Olga, additional, Sanmartin Berglund, Johan, additional, Schattner, Ariah, additional, Selleslag, Dominik, additional, Sinisalo, Marjatta, additional, Sultan, Faisal, additional, Theunissen, Koen, additional, Turner, Paul, additional, Wang, Po-Nan, additional, Yáñez San Segundo, Lucrecia, additional, Young, Jo-Anne, additional, Zachee, Pierre, additional, and Zaja, Francesco, additional

Published
2019
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21. 149. Immunogenicity, Safety, and Post-hoc Efficacy Assessment of the Adjuvanted Recombinant Zoster Vaccine in Adults with Hematologic Malignancies: A Phase 3, Randomized Clinical Trial

Author

Dagnew, Alemnew F, primary, Ilhan, Osman, additional, Lee, Won-Sik, additional, Woszczyk, Dariusz, additional, Kwak, Jae-Yong, additional, Bowcock, Stella, additional, Sohn, Sang Kyun, additional, Rodriguez Macías, Gabriela, additional, Chiou, Tzeon-Jye, additional, Quiel, Dimas, additional, Aoun, Mickael, additional, Matilla, Maria Belen Navarro, additional, De La Serna, Javier, additional, Milliken, Samuel, additional, Murphy, John, additional, McNeil, Shelly A, additional, Salaun, Bruno, additional, Paolo, Emmanuel Di, additional, Campora, Laura, additional, López-Fauqued, Marta, additional, El Idrissi, Mohamed, additional, Schuind, Anne, additional, Heineman, Thomas C, additional, Van Den Steen, Peter, additional, and Oostvogels, Lidia, additional

Published
2018
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22. Treatment outcomes in patients with proven/probable vs possible invasive mould disease in a phase III trial comparing isavuconazole vs voriconazole

Author

Maertens, Johan, Selleslag, Dominik, Heinz, Werner J., Saulay, Mikael, Rahav, Galia, Giladi, Michael, Aoun, Mickael, Kovanda, Laura, Kaufhold, Achim, Engelhardt, Marc, Cornely, Oliver A., Herbrecht, Raoul, Ullmann, Andrew J., Maertens, Johan, Selleslag, Dominik, Heinz, Werner J., Saulay, Mikael, Rahav, Galia, Giladi, Michael, Aoun, Mickael, Kovanda, Laura, Kaufhold, Achim, Engelhardt, Marc, Cornely, Oliver A., Herbrecht, Raoul, and Ullmann, Andrew J.

Abstract

Treatment outcomes in patients with proven/probable vs possible invasive mould disease (IMD; 2008 European Organisation for Research and Treatment of Cancer/Mycoses Study Group [EORTC/MSG] criteria) needed further assessment. The Phase III SECURE trial compared isavuconazole vs voriconazole for treatment of IMD. This post hoc analysis assessed all-cause mortality (ACM) through day 42 (primary endpoint) and day 84, overall and clinical success at end of treatment (EOT), and drug-related treatment-emergent adverse events (TEAEs) in subgroups with proven/probable or possible IMD. Of 516 randomised patients, 304 (58.9%) had proven/probable IMD and 164 (31.8%) had possible IMD as per EORTC/MSG criteria; 48 did not have IMD. Across treatment groups, day 42 and day 84 ACM were numerically lower for possible vs proven/probable IMD (day 42: 17.1% vs 21.1%; P=0.3, day 84: 26.2% vs 32.6%; P=0.15). Overall and clinical success at EOT were significantly higher for possible IMD compared with proven/probable IMD (48.2% vs 36.2%; P=0.01, 75.0% vs 63.1%; P=0.01 respectively). Fewer drug-related TEAEs were reported with isavuconazole compared with voriconazole in patients with either proven/probable or possible IMD. Compared with patients with proven/probable IMD, those with possible IMD demonstrated higher overall and clinical success rates, supporting early initiation of antifungal treatment.

Published
2018

25. Treatment outcomes in patients with proven/probable vs possible invasive mould disease in a phase III trial comparing isavuconazole vs voriconazole

Author

Maertens, Johan, primary, Selleslag, Dominik, additional, Heinz, Werner J., additional, Saulay, Mikael, additional, Rahav, Galia, additional, Giladi, Michael, additional, Aoun, Mickael, additional, Kovanda, Laura, additional, Kaufhold, Achim, additional, Engelhardt, Marc, additional, Cornely, Oliver A., additional, Herbrecht, Raoul, additional, and Ullmann, Andrew J., additional

Published
2018
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26. Pharmacokinetics and safety results from the Phase 3 randomized, open-label, study of intravenous posaconazole in patients at risk of invasive fungal disease

Author

Cornely, Oliver A., Robertson, Michael N., Haider, Shariq, Grigg, Andrew, Geddes, Michelle, Aoun, Mickael, Heinz, Werner J., Raad, Issam, Schanz, Urs, Meyer, Ralf G., Hammond, Sarah P., Mullane, Kathleen M., Ostermann, Helmut, Ullmann, Andrew J., Zimmerli, Stefan, Van Iersel, M. L. P. S., Hepler, Deborah A., Waskin, Hetty, Kartsonis, Nicholas A., Maertens, Johan, Cornely, Oliver A., Robertson, Michael N., Haider, Shariq, Grigg, Andrew, Geddes, Michelle, Aoun, Mickael, Heinz, Werner J., Raad, Issam, Schanz, Urs, Meyer, Ralf G., Hammond, Sarah P., Mullane, Kathleen M., Ostermann, Helmut, Ullmann, Andrew J., Zimmerli, Stefan, Van Iersel, M. L. P. S., Hepler, Deborah A., Waskin, Hetty, Kartsonis, Nicholas A., and Maertens, Johan

Abstract

Objectives: A two-part (Phase 1B/3), sequential, open-label, multicentre study evaluated the pharmacokinetics (PK) and safety of intravenous (iv) posaconazole given as antifungal prophylaxis to neutropenic patients with AML or myelodysplastic syndrome (MDS) or to recipients at risk of invasive fungal disease (IFD) after allogeneic HSCT. Methods: Patients (N=237) received 300mg of posaconazole iv twice daily on day 1, followed by 300mg of posaconazole iv once daily for 4-28 days. After at least 5 days, patients were randomly assigned to receive posaconazole oral suspension, 400mg twice daily or 200mg three times daily, to complete a 28 day treatment course. Primary PK parameters were steady-state average concentration over the dosing interval (C-avg) and posaconazole trough levels (C-min). Results: Mean posaconazole C-min was 1320 ng/mL (day 6) and 1297 ng/mL (day 8); steady-state C-min was 1090 ng/mL (day 10). Mean steady-state posaconazole C-avg was 1500 ng/mL (day 10 or 14) and was similar in HSCT recipients (1560 ng/mL) and AML/MDS patients (1470 ng/mL). The most commonly reported treatment-related adverse events were diarrhoea (8%), nausea (5%) and rash (5%). IFD was reported in 3/237 patients (1%; 2 proven, 1 probable). Conclusions: Intravenous posaconazole at 300mg was well tolerated, resulted in adequate steady-state systemic exposure and was associated with a low incidence of IFD in this population at high risk.

Published
2017

27. A Randomized, Blinded, Multicenter Trial of Lipid-Associated Amphotericin B Alone versus in Combination with an Antibody-Based Inhibitor of Heat Shock Protein 90 in Patients with Invasive Candidiasis

Author

Pachl, Jan, Svoboda, Petr, Jacobs, Frédérique, Vandewoude, Koenraad, van der Hoven, Ben, Spronk, Peter, Masterson, Gary, Malbrain, Manu, Aoun, Mickael, Garbino, Jorge, Takala, Jukka, Drgona, Lubos, Burnie, James, Matthews, Ruth, Pachl, Jan, Svoboda, Petr, Jacobs, Frédérique, Vandewoude, Koenraad, van der Hoven, Ben, Spronk, Peter, Masterson, Gary, Malbrain, Manu, Aoun, Mickael, Garbino, Jorge, Takala, Jukka, Drgona, Lubos, Burnie, James, and Matthews, Ruth

Abstract

Background. Mycograb (NeuTec Pharma) is a human recombinant monoclonal antibody against heat shock protein 90 that, in laboratory studies, was revealed to have synergy with amphotericin B against a broad spectrum of Candida species. Methods. A double-blind, randomized study was conducted to determine whether lipid-associated amphotericin B plus Mycograb was superior to amphotericin B plus placebo in patients with culture-confirmed invasive candidiasis. Patients received a lipid-associated formulation of amphotericin B plus a 5-day course of Mycograb or placebo, having been stratified on the basis of Candida species (Candida albicans vs. non-albicans species of Candida). Inclusion criteria included clinical evidence of active infection at trial entry plus growth of Candida species on culture of a specimen from a clinically significant site within 3 days after initiation of study treatment. The primary efficacy variable was overall response to treatment (clinical and mycological resolution) by day 10. Results. Of the 139 patients enrolled from Europe and the United States, 117 were included in the modified intention-to-treat population. A complete overall response by day 10 was obtained for 29 (48%) of 61 patients in the amphotericin B group, compared with 47 (84%) of 56 patients in the Mycograb combination therapy group (odds ratio [OR], 5.8; 95% confidence interval [CI], 2.41-13.79; P < .001). The following efficacy criteria were also met: clinical response (52% vs. 86%; OR, 5.4; 95% CI, 2.21-13.39; P < .001), mycological response (54% vs. 89%; OR, 7.1; 95% CI, 2.64-18.94; P < .001), Candida-attributable mortality (18% vs. 4%; OR, 0.2; 95% CI, 0.04-0.80; P = .025), and rate of culture-confirmed clearance of the infection (hazard ratio, 2.3; 95% CI, 1.4-3.8; P = .001). Mycograb was well tolerated. Conclusions. Mycograb plus lipid-associated amphotericin B produced significant clinical and culture-confirmed improvement in outcome for patients with invasive candidiasis

Published
2017

28. Pharmacokinetics and safety results from the Phase 3 randomized, open-label, study of intravenous posaconazole in patients at risk of invasive fungal disease

Author

Cornely, Oliver A, primary, Robertson, Michael N, additional, Haider, Shariq, additional, Grigg, Andrew, additional, Geddes, Michelle, additional, Aoun, Mickael, additional, Heinz, Werner J, additional, Raad, Issam, additional, Schanz, Urs, additional, Meyer, Ralf G, additional, Hammond, Sarah P, additional, Mullane, Kathleen M, additional, Ostermann, Helmut, additional, Ullmann, Andrew J, additional, Zimmerli, Stefan, additional, Van Iersel, M L P S, additional, Hepler, Deborah A, additional, Waskin, Hetty, additional, Kartsonis, Nicholas A, additional, and Maertens, Johan, additional

Published
2017
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29. Isavuconazole versus voriconazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentous fungi (SECURE): a phase 3, randomised-controlled, non-inferiority trial

Author

Maertens, Johan A., Raad, Issam I., Marr, Kieren A., Patterson, Thomas F., Kontoyiannis, Dimitrios P., Cornely, Oliver A., Bow, Eric J., Rahav, Galia, Neofytos, Dionysios, Aoun, Mickael, Baddley, John W., Giladi, Michael, Heinz, Werner J., Herbrecht, Raoul, Hope, William, Karthaus, Meinolf, Lee, Dong-Gun, Lortholary, Olivier, Morrison, Vicki A., Oren, Ilana, Selleslag, Dominik, Shoham, Shmuel, Thompson, George R., III, Lee, Misun, Maher, Rochelle M., Schmitt-Hoffmann, Anne-Hortense, Zeiher, Bernhardt, Ullmann, Andrew J., Maertens, Johan A., Raad, Issam I., Marr, Kieren A., Patterson, Thomas F., Kontoyiannis, Dimitrios P., Cornely, Oliver A., Bow, Eric J., Rahav, Galia, Neofytos, Dionysios, Aoun, Mickael, Baddley, John W., Giladi, Michael, Heinz, Werner J., Herbrecht, Raoul, Hope, William, Karthaus, Meinolf, Lee, Dong-Gun, Lortholary, Olivier, Morrison, Vicki A., Oren, Ilana, Selleslag, Dominik, Shoham, Shmuel, Thompson, George R., III, Lee, Misun, Maher, Rochelle M., Schmitt-Hoffmann, Anne-Hortense, Zeiher, Bernhardt, and Ullmann, Andrew J.

Abstract

Background Isavuconazole is a novel triazole with broad-spectrum antifungal activity. The SECURE trial assessed efficacy and safety of isavuconazole versus voriconazole in patients with invasive mould disease. Methods This was a phase 3, double-blind, global multicentre, comparative-group study. Patients with suspected invasive mould disease were randomised in a 1: 1 ratio using an interactive voice-web response system, stratified by geographical region, allogeneic haemopoietic stem cell transplantation, and active malignant disease at baseline, to receive isavuconazonium sulfate 372 mg (prodrug; equivalent to 200 mg isavuconazole; intravenously three times a day on days 1 and 2, then either intravenously or orally once daily) or voriconazole (6 mg/kg intravenously twice daily on day 1, 4 mg/kg intravenously twice daily on day 2, then intravenously 4 mg/kg twice daily or orally 200 mg twice daily from day 3 onwards). We tested non-inferiority of the primary efficacy endpoint of all-cause mortality from first dose of study drug to day 42 in patients who received at least one dose of the study drug (intention-to-treat [ITT] population) using a 10% non-inferiority margin. Safety was assessed in patients who received the first dose of study drug. This study is registered with ClinicalTrials.gov, number NCT00412893. Findings 527 adult patients were randomly assigned (258 received study medication per group) between March 7, 2007, and March 28, 2013. All-cause mortality from first dose of study drug to day 42 for the ITT population was 19% with isavuconazole (48 patients) and 20% with voriconazole (52 patients), with an adjusted treatment difference of -1.0% (95% CI -7.8 to 5.7). Because the upper bound of the 95% CI (5.7%) did not exceed 10%, non-inferiority was shown. Most patients (247 [96%] receiving isavuconazole and 255 [98%] receiving voriconazole) had treatment-emergent adverse events (p=0.122); the most common were gastrointestinal disorders (174 [68%] vs 180 [69

Published
2016

30. Hepatic Safety of Isavuconazole Compared With Voriconazole in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation Complicated by Invasive Mold Disease: A Post-Hoc Analysis From the SECURE Study

Author

Heinz, Werner J., primary, Cornely, Oliver A., additional, Selleslag, Dominik, additional, Rahav, Galia, additional, Giladi, Michael, additional, Aoun, Mickael, additional, Herbrecht, Raoul, additional, Ullmann, Andrew J., additional, Azie, Nkechi, additional, Kovanda, Laura, additional, Kaufhold, Achim, additional, Engelhardt, Marc, additional, and Maertens, Johan, additional

Published
2016
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31. Detection of Herpesviridae in Whole Blood by Multiplex PCR DNA-Based Microarray Analysis after Hematopoietic Stem Cell Transplantation.

Author

Debaugnies, France, Busson, Laurent, Ferster, Alina, Lewalle, Philippe, Azzi, Nadira, Aoun, Mickael, Verhaegen, Georges, Mahadeb, Bhavna, de Marchin, Jérôme, Vandenberg, Olivier, Hallin, Marie, Debaugnies, France, Busson, Laurent, Ferster, Alina, Lewalle, Philippe, Azzi, Nadira, Aoun, Mickael, Verhaegen, Georges, Mahadeb, Bhavna, de Marchin, Jérôme, Vandenberg, Olivier, and Hallin, Marie

Abstract

Viral infections are important causes of morbidity and mortality in patients after hematopoietic stem cell transplantation. The monitoring by PCR of Herpesviridae loads in blood samples has become a critical part of posttransplant follow-up, representing mounting costs for the laboratory. In this study, we assessed the clinical performance of the multiplex PCR DNA microarray Clart Entherpex kit for detection of cytomegalovirus (CMV), Epstein-Barr virus (EBV), and human herpesvirus 6 (HHV-6) as a screening test for virological follow-up. Two hundred fifty-five blood samples from 16 transplanted patients, prospectively tested by routine PCR assays, were analyzed by microarray. Routine PCR detected single or multiple viruses in 42% and 10% of the samples, respectively. Microarray detected single or multiple viruses in 34% and 18% of the samples, respectively. Microarray results correlated well with CMV and EBV detections by routine PCR (kappa tests = 0.79 and 0.78, respectively), whereas a weak correlation was observed with HHV-6 (0.43). HHV-7 was also detected in 48 samples by microarray. In conclusion, the microarray is a reliable screening assay for a posttransplant virological follow-up to detect CMV and EBV infections in blood. However, positive samples must be subsequently confirmed and viral loads must be quantified by PCR assays. Limitations were identified regarding HHV-6 detection. Although it is promising, is easy to use as a first-line test, and allows a reduction in the cost of analysis without undue delay in the reporting of the final quantitative result to the clinician, some characteristics of this microarray should be improved, particularly regarding quality control and the targeted virus panel, such that it could then be used as a routine test., Journal Article, SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2014

32. Detection of Herpesviridae in Whole Blood by Multiplex PCR DNA-Based Microarray Analysis after Hematopoietic Stem Cell Transplantation

Author

Debaugnies, France, primary, Busson, Laurent, additional, Ferster, Alina, additional, Lewalle, Philippe, additional, Azzi, Nadira, additional, Aoun, Mickael, additional, Verhaegen, Godelieve, additional, Mahadeb, Bhavna, additional, de Marchin, Jérôme, additional, Vandenberg, Olivier, additional, and Hallin, Marie, additional

Published
2014
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33. The Sanford Guide to Antimicrobial Therapy 2012-2013

Author

Aoun, Mickael, Buyle, Franky, DeWit, Stephane, Haegeman, Evelien, Kestelyn, Philippe, Kolivras, Athanassios, Rodriguez Villalobos, Hector, Sergysels, Roger, Valcke, Yvan, Van Bambeke, Françoise, Vandekerckhove, Linos, Van Gompel, Fons, Van Wijngaerden, Eric, Aoun, Mickael, Buyle, Franky, DeWit, Stephane, Haegeman, Evelien, Kestelyn, Philippe, Kolivras, Athanassios, Rodriguez Villalobos, Hector, Sergysels, Roger, Valcke, Yvan, Van Bambeke, Françoise, Vandekerckhove, Linos, Van Gompel, Fons, and Van Wijngaerden, Eric

Abstract

0, info:eu-repo/semantics/published

Published
2012

39. Isavuconazole versus voriconazole for primary treatment of invasive mould disease caused by Aspergillusand other filamentous fungi (SECURE): a phase 3, randomised-controlled, non-inferiority trial

Author

Maertens, Johan A, Raad, Issam I, Marr, Kieren A, Patterson, Thomas F, Kontoyiannis, Dimitrios P, Cornely, Oliver A, Bow, Eric J, Rahav, Galia, Neofytos, Dionysios, Aoun, Mickael, Baddley, John W, Giladi, Michael, Heinz, Werner J, Herbrecht, Raoul, Hope, William, Karthaus, Meinolf, Lee, Dong-Gun, Lortholary, Olivier, Morrison, Vicki A, Oren, Ilana, Selleslag, Dominik, Shoham, Shmuel, Thompson, George R, Lee, Misun, Maher, Rochelle M, Schmitt-Hoffmann, Anne-Hortense, Zeiher, Bernhardt, and Ullmann, Andrew J

Abstract

Isavuconazole is a novel triazole with broad-spectrum antifungal activity. The SECURE trial assessed efficacy and safety of isavuconazole versus voriconazole in patients with invasive mould disease.

Published
2016
Full Text
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40. Detection of Herpesviridaein Whole Blood by Multiplex PCR DNA-Based Microarray Analysis after Hematopoietic Stem Cell Transplantation

Author

Debaugnies, France, Busson, Laurent, Ferster, Alina, Lewalle, Philippe, Azzi, Nadira, Aoun, Mickael, Verhaegen, Godelieve, Mahadeb, Bhavna, de Marchin, Jérôme, Vandenberg, Olivier, and Hallin, Marie

Abstract

ABSTRACTViral infections are important causes of morbidity and mortality in patients after hematopoietic stem cell transplantation. The monitoring by PCR of Herpesviridaeloads in blood samples has become a critical part of posttransplant follow-up, representing mounting costs for the laboratory. In this study, we assessed the clinical performance of the multiplex PCR DNA microarray Clart Entherpex kit for detection of cytomegalovirus (CMV), Epstein-Barr virus (EBV), and human herpesvirus 6 (HHV-6) as a screening test for virological follow-up. Two hundred fifty-five blood samples from 16 transplanted patients, prospectively tested by routine PCR assays, were analyzed by microarray. Routine PCR detected single or multiple viruses in 42% and 10% of the samples, respectively. Microarray detected single or multiple viruses in 34% and 18% of the samples, respectively. Microarray results correlated well with CMV and EBV detections by routine PCR (kappa tests = 0.79 and 0.78, respectively), whereas a weak correlation was observed with HHV-6 (0.43). HHV-7 was also detected in 48 samples by microarray. In conclusion, the microarray is a reliable screening assay for a posttransplant virological follow-up to detect CMV and EBV infections in blood. However, positive samples must be subsequently confirmed and viral loads must be quantified by PCR assays. Limitations were identified regarding HHV-6 detection. Although it is promising, is easy to use as a first-line test, and allows a reduction in the cost of analysis without undue delay in the reporting of the final quantitative result to the clinician, some characteristics of this microarray should be improved, particularly regarding quality control and the targeted virus panel, such that it could then be used as a routine test.

Published
2014
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41. Zygomycosis in the immunocompromised patient: a case report.

Author

Georgala A, Vekemans M, Husson M, Meuleman N, Beguin H, Nolard N, and Aoun M

Subjects
Acute Disease, Aerosols, Amphotericin B administration & dosage, Amsacrine administration & dosage, Antibiotic Prophylaxis, Antifungal Agents administration & dosage, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Combined Modality Therapy, Cytarabine administration & dosage, Daunorubicin administration & dosage, Debridement, Drug Resistance, Fungal, Drug Resistance, Neoplasm, Etoposide administration & dosage, Fluconazole therapeutic use, Humans, Immunocompromised Host, Leukemia complications, Leukemia drug therapy, Liposomes, Middle Aged, Mucormycosis microbiology, Mucormycosis surgery, Sinusitis diagnostic imaging, Sinusitis microbiology, Sinusitis surgery, Tomography, X-Ray Computed, Absidia isolation & purification, Amphotericin B therapeutic use, Antifungal Agents therapeutic use, Mucormycosis drug therapy, Sinusitis drug therapy
Abstract

Zygomycosis is a highly aggressive infection observed in immunocompromised patients, such as those with haematological malignancies. The sites most frequently involved are the sinuses and the lungs. New diagnostic tools and new antifungal treatments are essential in order to diagnose early and treat efficiently infections due to moulds. We report a case of sinusitis due to Absidia corymbifera occurring during chemotherapy-induced bone marrow aplasia in a patient with acute leukaemia. The sinusitis was successfully treated with AmBisome, and surgical debridement.

Published
2006

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