Search

Your search keyword '"Ader, Florence"' showing total 270 results
Start Over Author "Ader, Florence" Search Limiters Full Text Publication Year Range Last 10 years
270 results on '"Ader, Florence"'

1. Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial

Author

Trøseid, Marius, Arribas, José R., Assoumou, Lambert, Holten, Aleksander Rygh, Poissy, Julien, Terzić, Vida, Mazzaferri, Fulvia, Baño, Jesús Rodríguez, Eustace, Joe, Hites, Maya, Joannidis, Michael, Paiva, José-Artur, Reuter, Jean, Püntmann, Isabel, Patrick-Brown, Thale D. J. H., Westerheim, Elin, Nezvalova-Henriksen, Katerina, Beniguel, Lydie, Dahl, Tuva Børresdatter, Bouscambert, Maude, Halanova, Monika, Péterfi, Zoltán, Tsiodras, Sotirios, Rezek, Michael, Briel, Matthias, Ünal, Serhat, Schlegel, Martin, Ader, Florence, Lacombe, Karine, Amdal, Cecilie Delphin, Rodrigues, Serge, Tonby, Kristian, Gaudet, Alexandre, Heggelund, Lars, Mootien, Joy, Johannessen, Asgeir, Møller, Jannicke Horjen, Pollan, Beatriz Diaz, Tveita, Anders Aune, Kildal, Anders Benjamin, Richard, Jean-Christophe, Dalgard, Olav, Simensen, Victoria Charlotte, Baldé, Aliou, de Gastines, Lucie, del Álamo, Marta, Aydin, Burç, Lund-Johansen, Fridtjof, Trabaud, Mary-Anne, Diallo, Alpha, Halvorsen, Bente, Røttingen, John-Arne, Tacconelli, Evelina, Yazdanpanah, Yazdan, Olsen, Inge C., and Costagliola, Dominique

Published
2023
Full Text
View/download PDF

5. Tixagevimab-cilgavimab (AZD7442) for the treatment of patients hospitalized with COVID-19 (DisCoVeRy): A phase 3, randomized, double-blind, placebo-controlled trial

Author

Hites, Maya, primary, Massonnaud, Clément R., additional, Lapique, Eva Larranaga, additional, Belhadi, Drifa, additional, Jamard, Simon, additional, Goehringer, François, additional, Danion, François, additional, Reignier, Jean, additional, de Castro, Nathalie, additional, Garot, Denis, additional, Lacombe, Karine, additional, Tolsma, Violaine, additional, Faure, Emmanuel, additional, Malvy, Denis, additional, Staub, Thérèse, additional, Courjon, Johan, additional, Cazenave-Roblot, France, additional, Dyrhol Riise, Anne Ma, additional, Leturnier, Paul, additional, Martin-Blondel, Guillaume, additional, Roger, Claire, additional, Akinosoglou, Karolina, additional, Moing, Vincent Le, additional, Piroth, Lionel, additional, Sellier, Pierre, additional, Lescure, Xavier, additional, Trøseid, Marius, additional, Clevenbergh, Philippe, additional, Dalgard, Olav, additional, Gallien, Sébastien, additional, Gousseff, Marie, additional, Loubet, Paul, additional, Vardon-Bounes, Fanny, additional, Visée, Clotilde, additional, Belkhir, Leila, additional, Botelho-Nevers, Élisabeth, additional, Cabié, André, additional, Kotanidou, Anastasia, additional, Lanternier, Fanny, additional, Rouveix-Nordon, Elisabeth, additional, Silva, Susana, additional, Thiery, Guillaume, additional, Poignard, Pascal, additional, Carcelain, Guislaine, additional, Diallo, Alpha, additional, Mercier, Noémie, additional, Terzic, Vida, additional, Bouscambert-Duchamp, Maude, additional, Gaymard, Alexandre, additional, Trabaud, Mary-Anne, additional, Destras, Grégory, additional, Josset, Laurence, additional, Billard, Nicolas, additional, Han, Thi-Hong-Lien, additional, Guedj, Jérémie, additional, Couffin-Cadiergues, Sandrine, additional, Dechanet, Aline, additional, Delmas, Christelle, additional, Esperou, Hélène, additional, Fougerou-Leurent, Claire, additional, Mestre, Soizic Le, additional, Métois, Anabelle, additional, Noret, Marion, additional, Bally, Isabelle, additional, Dergan-Dylon, Sebastián, additional, Tubiana, Sarah, additional, Kalif, Ouifiya, additional, Bergaud, Nathalie, additional, Leveau, Benjamin, additional, Eustace, Joe, additional, Greil, Richard, additional, Hajdu, Edit, additional, Halanova, Monika, additional, Paiva, Jose-Artur, additional, Piekarska, Anna, additional, Rodriguez Baño, Jesus, additional, Tonby, Kristian, additional, Trojánek, Milan, additional, Tsiodras, Sotirios, additional, Unal, Serhat, additional, Burdet, Charles, additional, Costagliola, Dominique, additional, Yazdanpanah, Yazdan, additional, Peiffer-Smadja, Nathan, additional, Mentré, France, additional, and Ader, Florence, additional

Published
2024
Full Text
View/download PDF

6. Co-infection with Legionella and SARS-CoV-2, France, March 2020

Author

Allam, Camille, Gaymard, Alexandre, Descours, Ghislaine, Ginevra, Christophe, Josset, Laurence, Bouscambert, Maud, Beraud, Laetitia, Ibranosyan, Marine, Golfier, Camille, Friggeri, Arnaud, Lina, Bruno, Campese, Christine, Ader, Florence, and Jarraud, Sophie

Subjects
Legionellosis -- Case studies -- Risk factors -- Diagnosis, Legionnaires' disease -- Case studies -- Risk factors -- Diagnosis, Comorbidity -- Case studies -- Risk factors, Health
Abstract

The coronavirus disease (COVID-19) pandemic spread to France in mid-February 2020 (1). Co-infections have been described in patients with COVID-19 (2,3), but only 3 co-infections with Legionella have been reported [...]

Published
2021
Full Text
View/download PDF

7. An open-label randomized controlled trial of the effect of lopinavir/ritonavir, lopinavir/ritonavir plus IFN-β-1a and hydroxychloroquine in hospitalized patients with COVID-19

Author

Ader, Florence, Peiffer-Smadja, Nathan, Poissy, Julien, Bouscambert-Duchamp, Maude, Belhadi, Drifa, Diallo, Alpha, Delmas, Christelle, Saillard, Juliette, Dechanet, Aline, Mercier, Noémie, Dupont, Axelle, Alfaiate, Toni, Lescure, François-Xavier, Raffi, François, Goehringer, François, Kimmoun, Antoine, Jaureguiberry, Stéphane, Reignier, Jean, Nseir, Saad, Danion, François, Clere-Jehl, Raphael, Bouiller, Kévin, Navellou, Jean-Christophe, Tolsma, Violaine, Cabié, André, Dubost, Clément, Courjon, Johan, Leroy, Sylvie, Mootien, Joy, Gaci, Rostane, Mourvillier, Bruno, Faure, Emmanuel, Pourcher, Valérie, Gallien, Sébastien, Launay, Odile, Lacombe, Karine, Lanoix, Jean-Philippe, Makinson, Alain, Martin-Blondel, Guillaume, Bouadma, Lila, Botelho-Nevers, Elisabeth, Gagneux-Brunon, Amandine, Epaulard, Olivier, Piroth, Lionel, Wallet, Florent, Richard, Jean-Christophe, Reuter, Jean, Staub, Thérèse, Lina, Bruno, Noret, Marion, Andrejak, Claire, Lê, Minh Patrick, Peytavin, Gilles, Hites, Maya, Costagliola, Dominique, Yazdanpanah, Yazdan, Burdet, Charles, and Mentré, France

Published
2021
Full Text
View/download PDF

8. New Approaches to Manage Infections in Transplant Recipients: Report From the 2023 GTI (Infection and Transplantation Group) Annual Meeting

Author

Serris, Alexandra, primary, Coussement, Julien, additional, Pilmis, Benoît, additional, De Lastours, Victoire, additional, Dinh, Aurélien, additional, Parquin, François, additional, Epailly, Eric, additional, Ader, Florence, additional, Lortholary, Olivier, additional, Morelon, Emmanuel, additional, Kamar, Nassim, additional, Forcade, Edouard, additional, Lebeaux, David, additional, Dumortier, Jérôme, additional, Conti, Filomena, additional, Lefort, Agnes, additional, Scemla, Anne, additional, and Kaminski, Hannah, additional

Published
2023
Full Text
View/download PDF

10. Association of baseline white blood cell counts with tuberculosis treatment outcome: a prospective multicentered cohort study

Author

Chedid, Carole, Kokhreidze, Eka, Tukvadze, Nestani, Banu, Sayera, Uddin, Mohammad Khaja Mafij, Biswas, Samanta, Russomando, Graciela, Acosta, Chyntia Carolina Díaz, Arenas, Rossana, Ranaivomanana, Paulo PR., Razafimahatratra, Crisca, Herindrainy, Perlinot, Rakotosamimanana, Niaina, Hamze, Monzer, Ismail, Mohamad Bachar, Bayaa, Rim, Berland, Jean-Luc, Delogu, Giovanni, Endtz, Hubert, Ader, Florence, Goletti, Delia, and Hoffmann, Jonathan

Published
2020
Full Text
View/download PDF

11. Efficacy and Safety of Revaccination against Tetanus, Diphtheria, Haemophilus influenzae Type b and Hepatitis B Virus in a Prospective Cohort of Adult Recipients of Allogeneic Hematopoietic Stem Cell Transplantation

Author

Conrad, Anne, Perry, Marielle, Langlois, Marie-Elodie, Labussière-Wallet, Hélène, Barraco, Fiorenza, Ducastelle-Leprêtre, Sophie, Larcher, Marie-Virginie, Balsat, Marie, Boccard, Mathilde, Chidiac, Christian, Ferry, Tristan, Roure-Sobas, Chantal, Salles, Gilles, Valour, Florent, and Ader, Florence

Published
2020
Full Text
View/download PDF

13. Evaluation of the safety and efficacy of XAV-19 in patients with COVID-19-induced moderate pneumonia: study protocol for a randomized, double-blinded, placebo-controlled phase 2 (2a and 2b) trial

Author

Gaborit, Benjamin, Vanhove, Bernard, Vibet, Marie-Anne, Le Thuaut, Aurélie, Lacombe, Karine, Dubee, Vincent, Ader, Florence, Ferre, Virginie, Vicaut, Eric, Orain, Jéremie, Le Bras, Morgane, Omnes, Anne, Berly, Laetitia, Jobert, Alexandra, Morineau-Le Houssine, Pascale, Botturi, Karine, Josien, Régis, Flet, Laurent, Degauque, Nicolas, Brouard, Sophie, Duvaux, Odile, Poinas, Alexandra, and Raffi, François

Published
2021
Full Text
View/download PDF

14. Use of covid-19 convalescent plasma to treat patients admitted to hospital for covid-19 with or without underlying immunodeficiency: open label, randomised clinical trial

Author

Lacombe, Karine, primary, Hueso, Thomas, additional, Porcher, Raphael, additional, Mekinian, Arsene, additional, Chiarabini, Thibault, additional, Georgin-Lavialle, Sophie, additional, Ader, Florence, additional, Saison, Julien, additional, Martin-Blondel, Guillaume, additional, De Castro, Nathalie, additional, Bonnet, Fabrice, additional, Cazanave, Charles, additional, Francois, Anne, additional, Morel, Pascal, additional, Hermine, Olivier, additional, Pourcher, Valerie, additional, Michel, Marc, additional, Lescure, Xavier, additional, Soussi, Nora, additional, Brun, Phillipe, additional, Pommeret, Fanny, additional, Sellier, Pierre, additional, Rousset, Stella, additional, Piroth, Lionel, additional, Michot, Jean-Marie, additional, Baron, Gabriel, additional, de Lamballerie, Xavier, additional, Mariette, Xavier, additional, Tharaux, Pierre-Louis, additional, Resche-Rigon, Matthieu, additional, Ravaud, Philippe, additional, Simon, Tabassome, additional, and Tiberghien, Pierre, additional

Published
2023
Full Text
View/download PDF

17. Association between SARS‐CoV‐2 viral kinetics and clinical score evolution in hospitalized patients.

Author

Néant, Nadège, Lingas, Guillaume, Gaymard, Alexandre, Belhadi, Drifa, Hites, Maya, Staub, Thérèse, Greil, Richard, Paiva, Jose‐Artur, Poissy, Julien, Peiffer‐Smadja, Nathan, Costagliola, Dominique, Yazdanpanah, Yazdan, Bouscambert‐Duchamp, Maude, Gagneux‐Brunon, Amandine, Ader, Florence, Mentré, France, Wallet, Florent, Burdet, Charles, and Guedj, Jérémie

Subjects
HOSPITAL patients, CORONAVIRUS disease treatment, EARLY warning score, COVID-19, VIRAL load
Abstract

The role of antiviral treatment in coronavirus disease 2019 hospitalized patients is controversial. To address this question, we analyzed simultaneously nasopharyngeal viral load and the National Early Warning Score 2 (NEWS‐2) using an effect compartment model to relate viral dynamics and the evolution of clinical severity. The model is applied to 664 hospitalized patients included in the DisCoVeRy trial (NCT04315948; EudraCT 2020‐000936‐23) randomly assigned to either standard of care (SoC) or SoC + remdesivir. Then we use the model to simulate the impact of antiviral treatments on the time to clinical improvement, defined by a NEWS‐2 score lower than 3 (in patients with NEWS‐2 <7 at hospitalization) or 5 (in patients with NEWS‐2 ≥7 at hospitalization), distinguishing between patients with low or high viral load at hospitalization. The model can fit well the different observed patients trajectories, showing that clinical evolution is associated with viral dynamics, albeit with large interindividual variability. Remdesivir antiviral activity was 22% and 78% in patients with low or high viral loads, respectively, which is not sufficient to generate a meaningful effect on NEWS‐2. However, simulations predicted that antiviral activity greater than 99% could reduce by 2 days the time to clinical improvement in patients with high viral load, irrespective of the NEWS‐2 score at hospitalization, whereas no meaningful effect was predicted in patients with low viral loads. Our results demonstrate that time to clinical improvement is associated with time to viral clearance and that highly effective antiviral drugs could hasten clinical improvement in hospitalized patients with high viral loads. [ABSTRACT FROM AUTHOR]

Published
2023
Full Text
View/download PDF

18. Effect of Swine Glyco-humanized Polyclonal Neutralizing Antibody on Survival and Respiratory Failure in Patients Hospitalized With Severe COVID-19: A Randomized, Placebo-Controlled Trial.

Author

Gaborit, Benjamin, Vanhove, Bernard, Lacombe, Karine, Guimard, Thomas, Hocqueloux, Laurent, Perrier, Ludivine, Dubee, Vincent, Ferre, Virginie, Bressollette, Celine, Josien, Régis, Thuaut, Aurélie Le, Vibet, Marie-Anne, Jobert, Alexandra, Dailly, Eric, Ader, Florence, Brouard, Sophie, Duvaux, Odile, Raffi, François, and group, for the POLYCOR study

Subjects
SARS-CoV-2, RESPIRATORY insufficiency, COVID-19, AUJESZKY'S disease virus
Abstract

Background We evaluated the safety and efficacy of XAV-19, an antispike glyco-humanized swine polyclonal neutralizing antibody in patients hospitalized with severe coronavirus disease 2019 (COVID-19). Methods This phase 2b clinical trial enrolled adult patients from 34 hospitals in France. Eligible patients had a confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 within 14 days of onset of symptoms that required hospitalization for low-flow oxygen therapy (<6 L/min of oxygen). Patients were randomly assigned to receive a single intravenous infusion of 2 mg/kg of XAV-19 or placebo. The primary end point was the occurrence of death or severe respiratory failure between baseline and day 15. Results Between January 12, 2021, and April 16, 2021, 398 patients were enrolled in the study and randomly assigned to XAV-19 or placebo. The modified intention-to-treat population comprised 388 participants who received full perfusion of XAV-19 (199 patients) or placebo (189 patients). The mean (SD) age was 59.8 (12.4) years, 249 (64.2%) individuals were men, and the median time (interquartile range) from symptom onset to enrollment was 9 (7–10) days. There was no statistically significant decrease in the cumulative incidence of death or severe respiratory failure through day 15 in the XAV-19 group vs the placebo group (53/199 [26.6%] vs 48/189 [25.4%]; adjusted risk difference, 0.6%; 95% CI, −6% to 7%; hazard ratio, 1.03; 95% CI, 0.64–1.66; P =.90). In the safety population, adverse events were reported in 75.4% of 199 patients in the XAV-19 group and in 76.3% of 190 patients in the placebo group through D29. Conclusions Among patients hospitalized with COVID-19 requiring low-flow oxygen therapy, treatment with a single intravenous dose of XAV-19, compared with placebo, did not show a significant difference in terms of disease progression at day 15. [ABSTRACT FROM AUTHOR]

Published
2023
Full Text
View/download PDF

19. Prospective Whole-Genome Sequencing in Tuberculosis Outbreak Investigation, France, 2017-2018

Author

Genestet, Charlotte, Tatai, Caroline, Berland, Jean-Luc, Claude, Jean- Baptiste, Westeel, Emilie, Hodille, Elisabeth, Fredenucci, Isabelle, Rasigade, Jean- Philippe, Ponsoda, Michael, Jacomo, Veronique, Vachee, Anne, Gaudart, Alice, Gaillard, Jean-Louis, Roux, Anne-Laure, Ader, Florence, Tararbit, Karim, Terpant, Garance, Bryant, Juliet E., Lina, Gerard, and Dumitrescu, Oana

Subjects
BCG -- Surveys, Genomes -- Surveys, Tuberculosis -- Genetic aspects -- Surveys, DNA sequencing -- Surveys, Genomics -- Surveys, Cities and towns, Health
Abstract

France is a low-prevalence country for tuberculosis (TB); mean incidence was 7.1 cases/100,000 inhabitants in 2015 (1). Auvergne-Rhone-Alpes is the region of France with the second highest prevalence of TB [...]

Published
2019
Full Text
View/download PDF

20. Implementation of a centralized pharmacovigilance system in academic pan‐European clinical trials: Experience from EU‐Response and conect4children consortia

Author

Terzić, Vida, primary, Levoyer, Léa, additional, Figarella, Mélanie, additional, Bigagli, Elisabetta, additional, Mercier, Noémie, additional, De Gastines, Lucie, additional, Gibowski, Séverine, additional, Trøseid, Marius, additional, Demotes, Jacques, additional, Olsen, Inge Christoffer, additional, Hites, Maya, additional, Ader, Florence, additional, Lopez, José Ramón Arribas, additional, Mentré, France, additional, Espérou, Hélène, additional, Costagliola, Dominique, additional, Røttingen, John‐Arne, additional, Poissy, Julien, additional, Rozé, Jean‐Christophe, additional, Warris, Adilia, additional, O'Leary, Jackie, additional, Fernandes, Ricardo M., additional, Assoumou, Lambert, additional, Hankard, Regis, additional, Turner, Mark A., additional, Yazdanpanah, Yazdan, additional, and Diallo, Alpha, additional

Published
2023
Full Text
View/download PDF

21. Implementation of a centralized pharmacovigilance system in academic pan-European clinical trials: Experience from EU-Response and conect4children consortia

Author

Terzić, Vida, Levoyer, Léa, Figarella, Mélanie, Bigagli, Elisabetta, Mercier, Noémie, De Gastines, Lucie, Gibowski, Séverine, Trøseid, Marius, Demotes, Jacques, Olsen, Inge Christoffer, Hites, Maya, Ader, Florence, Lopez, José Ramón Arribas, Mentré, France, Espérou, Hélène, Costagliola, Dominique, Røttingen, John-Arne, Poissy, Julien, Rozé, Jean-Christophe, Warris, Adilia, O'Leary, Jackie, Fernandes, Ricardo M, Assoumou, Lambert, Hankard, Regis, Turner, Mark A, Yazdanpanah, Yazdan, Diallo, Alpha, EU-Response safety group, c4c safety group, University of Zurich, and Diallo, Alpha

Subjects
3004 Pharmacology, 2736 Pharmacology (medical), 610 Medicine & health, 10027 Clinic for Neonatology
Published
2023

22. Outcomes of post-exposure vaccination by modified vaccinia Ankara to prevent mpox (formerly monkeypox): a retrospective observational study in Lyon, France, June to August 2022

Author

Merad, Yanis, primary, Gaymard, Alexandre, additional, Cotte, Laurent, additional, Perpoint, Thomas, additional, Alfaiate, Dulce, additional, Godinot, Matthieu, additional, Becker, Agathe, additional, Cannesson, Olivier, additional, Batalla, Anne-Sophie, additional, Oria-Yassir, Fatima, additional, Landré, Sophie, additional, Morfin, Florence, additional, Bouscambert, Maude, additional, Valour, Florent, additional, Ader, Florence, additional, and Conrad, Anne, additional

Published
2022
Full Text
View/download PDF

24. Cidofovir in the Treatment of BK Virus–Associated Hemorrhagic Cystitis after Allogeneic Hematopoietic Stem Cell Transplantation

Author

Philippe, Michael, Ranchon, Florence, Gilis, Lila, Schwiertz, Vérane, Vantard, Nicolas, Ader, Florence, Labussiere-Wallet, Hélène, Thomas, Xavier, Nicolini, Franck-Emmanuel, Wattel, Eric, Ducastelle-Leprêtre, Sophie, Barraco, Fiorenza, Lebras, Laure, Salles, Gilles, Michallet, Mauricette, and Rioufol, Catherine

Published
2016
Full Text
View/download PDF

25. Management of pharmacovigilance during the COVID-19 pandemic crisis by the safety department of an academic sponsor: Lessons learnt and challenges from the EU DisCoVeRy clinical trial

Author

Mercier, Noémie, Belhadi, Drifa, Dechanet, Aline, Delmas, Christelle, Saillard, Juliette, Dumousseaux, Marina, Le Mestre, Soizic, Fougerou-Leurent, Claire, Ferrane, Assia, Burdet, Charles, Espérou, Hélène, Ader, Florence, Hites, Maya, Peiffer-Smadja, Nathan, Poissy, Julien, Andrejak, Claire, Paiva, José Artur, Tacconelli, Evelina, Staub, Thérèse, Greil, Richard, Costagliola, Dominique, Mentre, France, Yazdanpanah, Yazdan, Diallo, Alpha, ANRS France Recherche Nord & sud Sida-hiv hépatites, 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, AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre d'investigation Clinique [CHU Bichat] - Épidémiologie clinique (CIC 1425), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut de Santé Publique, Université de Médecine Carol Davila, Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Pôle de Recherche Clinique [Paris] (PRC), Hospices Civils de Lyon (HCL), Centre International de Recherche en Infectiologie (CIRI), École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Université libre de Bruxelles (ULB), Unité de Glycobiologie Structurale et Fonctionnelle - UMR 8576 (UGSF), Université de Lille-Centre National de la Recherche Scientifique (CNRS), CHU Lille, CHU Amiens-Picardie, Agents infectieux, résistance et chimiothérapie - UR UPJV 4294 (AGIR ), Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie, Hospital de São João [Porto], Universitätsklinikum Tübingen - University Hospital of Tübingen, Eberhard Karls Universität Tübingen = Eberhard Karls University of Tuebingen, Centre Hospitalier de Luxembourg [Luxembourg] (CHL), and Paracelsus Medizinische Privatuniversität = Paracelsus Medical University (PMU)

Subjects
EU-RESPONSE, [SDV]Life Sciences [q-bio], pharmacovigilance, adverse event, COVID-19, pandemic crisis
Abstract

International audience; The current COVID-19 pandemic was an exceptional health situation, including for drug use. As there was no known effective drug for COVID-19 at the beginning of the pandemic, different drug candidates were proposed. In this article, we present the challenges for an academic Safety Department to manage the global safety of a European trial during the pandemic. The National Institute for Health and Medical Research (Inserm) conducted a European multicenter, open-label, randomized, controlled trial involving three repurposed and one-in development drugs (lopinavir/ritonavir, IFN-β1a, hydroxychloroquine, and remdesivir) in adults hospitalized with COVID-19. From 25 March 2020 to 29 May 2020, the Inserm Safety Department had to manage 585 Serious Adverse Events (SAEs) initial notification and 396 follow-up reports. The Inserm Safety Department's staff was mobilized to manage these SAEs and to report Expedited safety reports to the competent authorities within the legal timeframes. More than 500 queries were sent to the investigators due to a lack of or incoherent information on SAE forms. At the same time, the investigators were overwhelmed by the management of patients suffering from COVID-19 infection. These particular conditions of missing data and lack of accurate description of adverse events made evaluation of the SAEs very difficult, particularly the assessment of the causal role of each investigational medicinal product. In parallel, working difficulties were accentuated by the national lockdown, frequent IT tool dysfunctions, delayed implementation of monitoring and the absence of automatic alerts for SAE form modification. Although COVID-19 is a confounding factor per se, the delay in and quality of SAE form completion and the real-time medical analysis by the Inserm Safety Department were major issues in the quick identification of potential safety signals. To conduct a high-quality clinical trial and ensure patient safety, all stakeholders must take their roles and responsibilities.

Published
2023

26. Additional file 1 of Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial

Author

Trøseid, Marius, Arribas, José R., Assoumou, Lambert, Holten, Aleksander Rygh, Poissy, Julien, Terzić, Vida, Mazzaferri, Fulvia, Baño, Jesús Rodríguez, Eustace, Joe, Hites, Maya, Joannidis, Michael, Paiva, José-Artur, Reuter, Jean, Püntmann, Isabel, Patrick-Brown, Thale D. J. H., Westerheim, Elin, Nezvalova-Henriksen, Katerina, Beniguel, Lydie, Dahl, Tuva Børresdatter, Bouscambert, Maude, Halanova, Monika, Péterfi, Zoltán, Tsiodras, Sotirios, Rezek, Michael, Briel, Matthias, Ünal, Serhat, Schlegel, Martin, Ader, Florence, Lacombe, Karine, Amdal, Cecilie Delphin, Rodrigues, Serge, Tonby, Kristian, Gaudet, Alexandre, Heggelund, Lars, Mootien, Joy, Johannessen, Asgeir, Møller, Jannicke Horjen, Pollan, Beatriz Diaz, Tveita, Anders Aune, Kildal, Anders Benjamin, Richard, Jean-Christophe, Dalgard, Olav, Simensen, Victoria Charlotte, Baldé, Aliou, de Gastines, Lucie, del Álamo, Marta, Aydin, Burç, Lund-Johansen, Fridtjof, Trabaud, Mary-Anne, Diallo, Alpha, Halvorsen, Bente, Røttingen, John-Arne, Tacconelli, Evelina, Yazdanpanah, Yazdan, Olsen, Inge C., and Costagliola, Dominique

Abstract

Additional file 1. Online Appendix.

Published
2023
Full Text
View/download PDF

29. Immunocompromised patients have been neglected in COVID-19 trials: a call for action

Author

Trøseid, Marius, primary, Hentzien, Maxime, additional, Ader, Florence, additional, Cardoso, Sandra Wagner, additional, Arribas, Jose R., additional, Molina, Jean-Michel, additional, Mueller, Nicolas, additional, Hites, Maya, additional, Bonnet, Fabrice, additional, Manuel, Oriol, additional, Costagliola, Dominique, additional, Grinsztejn, Beatriz, additional, Olsen, Inge Christoffer, additional, Yazdapanah, Yazdan, additional, and Calmy, Alexandra, additional

Published
2022
Full Text
View/download PDF

31. Remdesivir and three other drugs for hospitalised patients with COVID-19: final results of the WHO Solidarity randomised trial and updated meta-analyses

Author

Pan, Hongchao, Peto, Richard, Henao-Restrepo, Ana-Maria, Preziosi, Marie-Pierre, Sathiyamoorthy, Vasee, Abdool Karim, Quarraisha, Alejandria, Marissa M, Hernández García, César, Kieny, Marie-Paule, Malekzadeh, Reza, Murthy, Srinivas, Reddy, K Srinath, Roses Periago, Mirta, Abi Hanna, Pierre, Abutidze, Akaki, Ader, Florence, Al-Bader, Abdullah M, Alhasawi, Almonther, Allum, Emma, Al Mawali, Adhra, Alotaibi, Athari, Alvarez-Moreno, Carlos A, Appadoo, Sheila, Arts, Derk, Asiri, Abdullah, Aukrust, Pål, Barratt-Due, Andreas, Bayih, Abebe Genetu, Beaumont, Helena, Bellani, Samir, Benassi, Virginia, Bhargava, Balram, Branca, Mattia, Cappel-Porter, Heike B C, Cerrato, Nery, Cheick Haidara, Fadima, Chow, Ting S, Como, Najada, Eustace, Joe, Gabunia, Tamar, García, Patricia J, Godbole, Sheela, Gotuzzo, Eduardo, Griskevicius, Laimonas, Hamra, Rasha, Hassan, Mariam, Hassany, Mohamed, Hutton, David, Irmansyah, Irmansyah, Jancoriene, Ligita, Khamis, Faryal, Kirwan, Jana, Kumar, Suresh, Lopardo, Gustavo, Lydon, Patrick, Magrini, Nicola, Manevska, Suzana, Manuel, Oriol, McGinty, Sibylle, Medina, Marco T, Mesa Rubio, María L, Miranda-Montoya, Maria C, Nel, Jeremy, Nunes, Estevao P, Perola, Markus, Portolés, Antonio, Rasmin, Menaldi, Raza, Aun, Rees, Helen, Reges, Paula, Rogers, Chris, Salami, Kolawole, Salvadori, Marina, Sauermann, Mamatha, Sinani, Narvina, Sow, Samba, Sterne, Jonathan A C, Stevanovikj, Milena, Tacconelli, Evelina, Tavares Maltez, Fernando Manuel, Teferi, Mekonnen, Tikkinen, Kari, Trelle, Sven, Tsertsvadze, Tengiz, Zaid, Hala, Rottingen, Arne, Swaminathan, Soumya, Ryan, Michael, Zablockienė, Birutė, Paulauskas, Mindaugas, and Sakalauskienė, Ugnė

Subjects
Adult, Alanine, General Medicine, World Health Organization, Antiviral Agents, Adenosine Monophosphate, Lopinavir, COVID-19 Drug Treatment, Oxygen, Treatment Outcome, Humans, Interferon beta-1a, Hydroxychloroquine, Randomized Controlled Trials as Topic
Abstract

Background: The Solidarity trial among COVID-19 inpatients has previously reported interim mortality analyses for four repurposed antiviral drugs. Lopinavir, hydroxychloroquine, and interferon (IFN)-β1a were discontinued for futility but randomisation to remdesivir continued. Here, we report the final results of Solidarity and meta-analyses of mortality in all relevant trials to date.Methods: Solidarity enrolled consenting adults (aged ≥18 years) recently hospitalised with, in the view of their doctor, definite COVID-19 and no contraindication to any of the study drugs, regardless of any other patient characteristics. Participants were randomly allocated, in equal proportions between the locally available options, to receive whichever of the four study drugs (lopinavir, hydroxychloroquine, IFN-β1a, or remdesivir) were locally available at that time or no study drug (controls). All patients also received the local standard of care. No placebos were given. The protocol specified primary endpoint was in-hospital mortality, subdivided by disease severity. Secondary endpoints were progression to ventilation if not already ventilated, and time-to-discharge from hospital. Final log-rank and Kaplan-Meier analyses are presented for remdesivir, and are appended for all four study drugs. Meta-analyses give weighted averages of the mortality findings in this and all other randomised trials of these drugs among hospital inpatients. Solidarity is registered with ISRCTN, ISRCTN83971151, and ClinicalTrials.gov, NCT04315948.Findings: Between March 22, 2020, and Jan 29, 2021, 14304 potentially eligible patients were recruited from 454 hospitals in 35 countries in all six WHO regions. After the exclusion of 83 (0·6%) patients with a refuted COVID-19 diagnosis or encrypted consent not entered into the database, Solidarity enrolled 14221 patients, including 8275 randomly allocated (1:1) either to remdesivir (ten daily infusions, unless discharged earlier) or to its control (allocated no study drug although remdesivir was locally available). Compliance was high in both groups. Overall, 602 (14·5%) of 4146 patients assigned to remdesivir died versus 643 (15·6%) of 4129 assigned to control (mortality rate ratio [RR] 0·91 [95% CI 0·82–1·02], p=0·12). Of those already ventilated, 151 (42·1%) of 359 assigned to remdesivir died versus 134 (38·6%) of 347 assigned to control (RR 1·13 [0·89–1·42], p=0·32). Of those not ventilated but on oxygen, 14·6% assigned to remdesivir died versus 16·3% assigned to control (RR 0·87 [0·76–0·99], p=0·03). Of 1730 not on oxygen initially, 2·9% assigned to remdesivir died versus 3·8% assigned to control (RR 0·76 [0·46–1·28], p=0·30). Combining all those not ventilated initially, 11·9% assigned to remdesivir died versus 13·5% assigned to control (RR 0·86 [0·76–0·98], p=0·02) and 14·1% versus 15·7% progressed to ventilation (RR 0·88 [0·77–1·00], p=0·04). The non-prespecified composite outcome of death or progression to ventilation occurred in 19·6% assigned to remdesivir versus 22·5% assigned to control (RR 0·84 [0·75–0·93], p=0·001). Allocation to daily remdesivir infusions (vs open-label control) delayed discharge by about 1 day during the 10-day treatment period. A meta-analysis of mortality in all randomised trials of remdesivir versus no remdesivir yielded similar findings.Interpretation: Remdesivir has no significant effect on patients with COVID-19 who are already being ventilated. Among other hospitalised patients, it has a small effect against death or progression to ventilation (or both).

Published
2022

32. A Simple-to-Perform ifn-γ mRNA Gene Expression Assay on Whole Blood Accurately Appraises Varicella Zoster Virus-Specific Cell-Mediated Immunity After Allogeneic Hematopoietic Stem Cell Transplantation

Author

Boccard, Mathilde, primary, Conrad, Anne, additional, Mouton, William, additional, Valour, Florent, additional, Roure-Sobas, Chantal, additional, Frobert, Emilie, additional, Rohmer, Barbara, additional, Alcazer, Vincent, additional, Labussière-Wallet, Hélène, additional, Ghesquières, Hervé, additional, Venet, Fabienne, additional, Brengel-Pesce, Karen, additional, Trouillet-Assant, Sophie, additional, and Ader, Florence, additional

Published
2022
Full Text
View/download PDF

33. Clinical Presentation, Diagnosis, and Bacterial Epidemiology of Peritoneal Tuberculosis in Two University Hospitals in France

Author

Cavalli, Zoé, Ader, Florence, Valour, Florent, Saison, Julien, Boussel, Loïc, Dumitrescu, Oana, Perpoint, Thomas, Chidiac, Christian, May, Thierry, Ferry, Tristan, Adelaïde, L., Ader, F., Biron, F., Boibieux, A., Bouaziz, A., Bouledrak, K., Braun, E., Broussolle, C., Carret, G., Catho, G., Charhon, N., Chidiac, C., Chumbi-Flores, W., Coppere, B., Couraud, S., Demontclos, M., Devouassoux, G., Dumitrescu, O., Ernesto, S., Ferry, T., Floret, D., Fredenucci, I., Freymond, N., Gardes, S., Gerbier-Colomban, S., Gillet, Y., Girard-Madoux, M. H., Goutelle, S., Grando, J., Grima, R., Hees, L., Hodille, E., Hot, A., Karsenty, J., Kiakouama-Maleka, L., Lina, G., Maury, J. M., Miailhes, P., Moreau, L., Nesme, P., Ninet, J., Perard, L., Perpoint, T., Perrot, E., Ranc, A. G., Rasigade, J. P., Reix, R., Renaud-Baron, A. S., Saison, J., Senechal, A., Sève, P., Souquet, P. J., van Thai, H., Tronc, F., Valour, F., Vanhems, P., and Lyon TB Study group

Published
2016
Full Text
View/download PDF

34. In-Depth Immunophenotyping With Mass Cytometry During TB Treatment Reveals New T-Cell Subsets Associated With Culture Conversion

Author

Chedid, Carole, primary, Andrieu, Thibault, additional, Kokhreidze, Eka, additional, Tukvadze, Nestani, additional, Biswas, Samanta, additional, Ather, Md. Fahim, additional, Uddin, Mohammad Khaja Mafij, additional, Banu, Sayera, additional, De Maio, Flavio, additional, Delogu, Giovanni, additional, Endtz, Hubert, additional, Goletti, Delia, additional, Vocanson, Marc, additional, Dumitrescu, Oana, additional, Hoffmann, Jonathan, additional, and Ader, Florence, additional

Published
2022
Full Text
View/download PDF

35. Class I/Class II HLA Evolutionary Divergence Ratio Is an Independent Marker Associated With Disease-Free and Overall Survival After Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia

Author

Daull, Anne-Marie, primary, Dubois, Valérie, additional, Labussière-Wallet, Hélène, additional, Venet, Fabienne, additional, Barraco, Fiorenza, additional, Ducastelle-Lepretre, Sophie, additional, Larcher, Marie-Virginie, additional, Balsat, Marie, additional, Gilis, Lila, additional, Fossard, Gaëlle, additional, Ghesquières, Hervé, additional, Heiblig, Maël, additional, Ader, Florence, additional, and Alcazer, Vincent, additional

Published
2022
Full Text
View/download PDF

37. Disappearance of FDG uptake on PET scan after antimicrobial therapy could help for the diagnosis of Coxiella burnetii spondylodiscitis

Author

Gaudé, Marine, Julien, Saison, Laurent, Frédéric, Ferry, Tristan, Perpoint, Thomas, Boibieux, André, Biron, François, Ader, Florence, Valour, Florent, Roux, Sandrine, Daoud, Fatiha, Lippman, Johanna, Braun, Evelyne, Vallat, Marie-Paule, Miailhes, Patrick, Chidiac, Christian, Gillet, Yves, Hees, Laure, Lustig, Sébastien, Neyret, Philippe, Reynaud, Olivier, Peltier, Adrien, Viste, Anthony, Bérard, Jean-Baptiste, Dalat, Frédéric, Cantin, Olivier, Desmarchelier, Romain, Vermersch, Thibault, Fessy, Michel-Henry, Barrey, Cédric, Signorelli, Francesco, Jouanneau, Emmanuel, Jacquesson, Timothée, Mojallal, Ali, Boucher, Fabien, Shipkov, Hristo, Ismail, Mehdi, Chateau, Joseph, Vandenesch, François, Rasigade, Jean-Philippe, Dupieux, Céline, Trouillet-Assant, Sophie, Morelec, Isabelle, Janier, Marc, Giammarile, Francesco, Tod, Michel, Gagnieu, Marie-Claude, Goutelle, Sylvain, and Mabrut, Eugénie

Published
2016
Full Text
View/download PDF

38. Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results

Author

Pan, Hongchao, Peto, Richard, Henao-Restrepo, Ana-Maria, Preziosi, Marie-Pierre, Sathiyamoorthy, Vasee, Abdool Karim, Quarraisha, Alejandria, Marissa M, Hernández García, César, Kieny, Marie-Paule, Malekzadeh, Reza, Murthy, Srinivas, Reddy, K Srinath, Roses Periago, Mirta, Abi Hanna, Pierre, Abutidze, Akaki, Ader, Florence, Al-Bader, Abdullah M, Alhasawi, Almonther, Allum, Emma, Al Mawali, Adhra, Alotaibi, Athari, Alvarez-Moreno, Carlos A, Appadoo, Sheila, Arts, Derk, Asiri, Abdullah, Aukrust, Pål, Barratt-Due, Andreas, Bayih, Abebe Genetu, Beaumont, Helena, Bellani, Samir, Benassi, Virginia, Bhargava, Balram, Branca, Mattia, Cappel-Porter, Heike B C, Cerrato, Nery, Cheick Haidara, Fadima, Chow, Ting S, Como, Najada, Eustace, Joe, Gabunia, Tamar, García, Patricia J, Godbole, Sheela, Gotuzzo, Eduardo, Griskevicius, Laimonas, Hamra, Rasha, Hassan, Mariam, Hassany, Mohamed, Hutton, David, Irmansyah, Irmansyah, Jancoriene, Ligita, Khamis, Faryal, Kirwan, Jana, Kumar, Suresh, Lopardo, Gustavo, Lydon, Patrick, Magrini, Nicola, Manevska, Suzana, Manuel, Oriol, McGinty, Sibylle, Medina, Marco T, Mesa Rubio, María L, Miranda-Montoya, Maria C, Nel, Jeremy, Nunes, Estevao P, Perola, Markus, Portolés, Antonio, Rasmin, Menaldi, Raza, Aun, Rees, Helen, Reges, Paula, Rogers, Chris, Salami, Kolawole, Salvadori, Marina, Sauermann, Mamatha, Sinani, Narvina, Sow, Samba, Sterne, Jonathan A C, Stevanovikj, Milena, Tacconelli, Evelina, Tavares Maltez, Fernando Manuel, Teferi, Mekonnen, Tikkinen, Kari, Trelle, Sven, Tsertsvadze, Tengiz, Zaid, Hala, Rottingen, Arne, Swaminathan, Soumya, and Ryan, Michael

Abstract

BACKGROUND World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs - remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a - in patients hospitalized with coronavirus disease 2019 (Covid-19). METHODS We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care). The intention-to-treat primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available but patient assigned to the same care without that drug). Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry. RESULTS At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan-Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P = 0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P = 0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P = 0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P = 0.11). No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration. CONCLUSIONS These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay. (Funded by the World Health Organization; ISRCTN Registry number, ISRCTN83971151; ClinicalTrials.gov number, NCT04315948.).

Published
2022
Full Text
View/download PDF

39. Accelerating clinical trial implementation in the context of the COVID-19 pandemic: challenges, lessons learned and recommendations from DisCoVeRy and the EU-SolidAct EU response group

Author

Diallo, Alpha Troseid, Marius Simensen, Victoria Charlotte and Boston, Anais Demotes, Jacques Olsen, Inge Christoffer and Chung, Florence Paiva, Jose Artur Hites, Maya Ader, Florence and Arribas, Jose Ramon Baratt-Due, Andreas Melien, Oyvind and Tacconelli, Evelina Staub, Therese Greil, Richard Tsiodras, Sotirios Briel, Matthias Esperou, Helene Mentre, France and Eustace, Joe Saillard, Juliette Delmas, Christelle LeMestre, Soizic Dumousseaux, Marina Costagliola, Dominique Rottingen, John-Arne Yazdanpanah, Yazdan EU-Response Investigators Grp

Published
2022

40. Impact of COVID-19 pandemic on antifungal consumption: a multicenter retrospective analysis.

Author

Bienvenu, Anne-Lise, Bestion, Audrey, Pradat, Pierre, Richard, Jean-Christophe, Argaud, Laurent, Guichon, Céline, Roux, Sandrine, Piriou, Vincent, Paillet, Carole, Leboucher, Gilles, the Antifungal study group, Ader, Florence, Aubrun, Frédéric, Besson, Charlotte, Bréant, Valentine, Doudet, Charlotte, Ducastelle-Leprêtre, Sophie, Dupont, Damien, Guillemin, Marie-Delphine, and Leray, Véronique

Abstract

Background: In the context of COVID-19 pandemic, antifungal overuse may have occurred in our hospitals as it has been previously reported for antibacterials. Methods: To investigate the impact of COVID-19 on antifungal consumption, a multicenter retrospective study including four medical sites and 14 intensive care units (ICU) was performed. Antifungal consumption and incidences of invasive fungal diseases before and during COVID-19 pandemic, for non-COVID-19 patients and COVID-19 patients, were described. Results: An increase in voriconazole consumption was observed in 2020 compared with 2019 for both the whole hospital and the ICU (+ 40.3% and + 63.7%, respectively), whereas the incidence of invasive aspergillosis significantly increased in slightly lower proportions in the ICU (+ 46%). Caspofungin consumption also increased in 2020 compared to 2019 for both the whole hospital and the ICU (+ 34.9% and + 17.0%, respectively) with an increased incidence of invasive candidiasis in the whole hospital and the ICU but in lower proportions (+ 20.0% and + 10.9%, respectively). Conclusions: We observed an increased consumption of antifungals including voriconazole and caspofungin in our hospital during the COVID-19 pandemic and explained in part by an increased incidence of invasive fungal diseases in COVID-19 patients. These results are of utmost importance as it raises concern about the urgent need for appropriate antifungal stewardship activities to control antifungal consumption. [ABSTRACT FROM AUTHOR]

Published
2022
Full Text
View/download PDF

41. Accelerating clinical trial implementation in the context of the COVID-19 pandemic: challenges, lessons learned and recommendations from DisCoVeRy and the EU-SolidAct EU response group

Author

Diallo, Alpha, Trøseid, Marius, Simensen, Victoria Charlotte, Boston, Anaïs, Demotes, Jacques, Olsen, Inge Christoffer, Chung, Florence, Paiva, José Artur, Hites, Maya, Ader, Florence, Arribas, Jose Ramon, Baratt-Due, Andreas, Melien, Øyvind, Tacconelli, Evelina, Staub, Thèrèse, Greil, Richard, Tsiodras, Sotirios, Briel, Matthias, Esperou, Hélène, Mentré, France, Eustace, Joe, Saillard, Juliette, Delmas, Christelle, LeMestre, Soizic, Dumousseaux, Marina, Costagliola, Dominique, Røttingen, John-Arne, and Yazdanpanah, Yazdan

Published
2022
Full Text
View/download PDF

42. Implementation of a complex bone and joint infection phage therapy centre in France: lessons to be learned after 4 years' experience

Author

Ferry, Tristan, primary, Kolenda, Camille, additional, Briot, Thomas, additional, Lustig, Sébastien, additional, Leboucher, Gilles, additional, Laurent, Frédéric, additional, Ferry, Tristan, additional, Valour, Florent, additional, Perpoint, Thomas, additional, Ader, Florence, additional, Roux, Sandrine, additional, Becker, Agathe, additional, Triffault-Fillit, Claire, additional, Conrad, Anne, additional, Pouderoux, Cécile, additional, Chauvelot, Pierre, additional, Chabert, Paul, additional, Lippman, Johanna, additional, Braun, Evelyne, additional, Servien, Elvire, additional, Batailler, Cécile, additional, Gunst, Stanislas, additional, Schmidt, Axel, additional, Sappey-Marinier, Eliott, additional, Ode, Quentin, additional, Fessy, Michel-Henry, additional, Viste, Anthony, additional, Besse, Jean-Luc, additional, Chaudier, Philippe, additional, Louboutin, Lucie, additional, Van Haecke, Adrien, additional, Mercier, Marcelle, additional, Belgaid, Vincent, additional, Gazarian, Aram, additional, Walch, Arnaud, additional, Bertani, Antoine, additional, Rongieras, Frédéric, additional, Martres, Sébastien, additional, Trouillet, Franck, additional, Barrey, Cédric, additional, Mojallal, Ali, additional, Brosset, Sophie, additional, Hanriat, Camille, additional, Person, Hélène, additional, Céruse, Philippe, additional, Fuchsmann, Carine, additional, Gleizal, Arnaud, additional, Aubrun, Frédéric, additional, Dziadzko, Mikhail, additional, Macabéo, Caroline, additional, Patrascu, Dana, additional, Beraud, Laetitia, additional, Roussel-Gaillard, Tiphaine, additional, Dupieux, Céline, additional, Josse, Jérôme, additional, Craighero, Fabien, additional, Boussel, Loic, additional, Pialat, Jean-Baptiste, additional, Morelec, Isabelle, additional, Tod, Michel, additional, Gagnieu, Marie-Claude, additional, Goutelle, Sylvain, additional, Mabrut, Eugénie, additional, Medina, Mathieu, additional, Laumay, Floriane, additional, Bonhomme, Melanie, additional, Blazere, Leslie, additional, Legendre, Tiphaine, additional, Terrazzoni, Eline, additional, Pirot, Fabrice, additional, Merienne, Camille, additional, Filali, Samira, additional, and Lapras, Benjamine, additional

Published
2022
Full Text
View/download PDF

43. Reactivation of Clostridium tertium bone infection 30 years after the Iran–Iraq war

Author

Virot, Emilie, Servien, Elvire, Laurent, Frederic, Ferry, Tristan, Perpoint, Thomas, Boibieux, André, Biron, François, Ader, Florence, Saison, Julien, Valour, Florent, Daoud, Fatiha, Lippman, Johanna, Braun, Evelyne, Vallat, Marie-Paule, Miailhes, Patrick, Chidiac, Christian, Peyramond, Dominique, Lustig, Sébastien, Neyret, Philippe, Reynaud, Olivier, Debette, Caroline, Peltier, Adrien, Viste, Anthony, Bérard, Jean-Baptiste, Dalat, Frédéric, Cantin, Olivier, Desmarchelier, Romain, Fessy, Michel-Henry, Barrey, Cédric, Signorelli, Francesco, Jouanneau, Emmanuel, Jacquesson, Timothée, Breton, Pierre, Mojallal, Ali, Boucher, Fabien, Shipkov, Hristo, Vandenesch, François, Rasigade, Jean-Philippe, Dupieux, Céline, Boussel, Loïc, Pialat, Jean-Baptiste, Morelec, Isabelle, Janier, Marc, Giammarile, Francesco, Tod, Michel, Gagnieu, Marie-Claude, Goutelle, Sylvain, and Mabrut, Eugénie

Published
2015
Full Text
View/download PDF

44. A 22-year-old woman with right lumpy jaw syndrome and fistula

Author

Valour, F, Chidiac, C, Ferry, T, Ferry, Tristan, Perpoint, Thomas, Boibieux, André, Biron, François, Ader, Florence, Saison, Julien, Valour, Florent, Daoud, Fatiha, Lippman, Johanna, Braun, Evelyne, Vallat, Marie-Paule, Miailhes, Patrick, Chidiac, Christian, Peyramond, Dominique, Lustig, Sébastien, Neyret, Philippe, Reynaud, Olivier, Debette, Caroline, Peltier, Adrien, Viste, Anthony, Bérard, Jean-Baptiste, Dalat, Frédéric, Cantin, Olivier, Desmarchelier, Romain, Vermersch, Thibault, Fessy, Michel-Henry, Barrey, Cédric, Signorelli, Francesco, Jouanneau, Emmanuel, Jacquesson, Timothée, Breton, Pierre, Mojallal, Ali, Boucher, Fabien, Shipkov, Hristo, Laurent, Frederic, Vandenesch, François, Rasigade, Jean-Philippe, Dupieux, Céline, Morelec, Isabelle, Janier, Marc, Giammarile, Francesco, Tod, Michel, Gagnieu, Marie-Claude, Goutelle, Sylvain, and Mabrut, Eugénie

Published
2015
Full Text
View/download PDF

45. Pharmacokinetics and Safety of XAV-19, a Swine Glyco-humanized Polyclonal Anti-SARS-CoV-2 Antibody, for COVID-19-Related Moderate Pneumonia: a Randomized, Double-Blind, Placebo-Controlled, Phase IIa Study

Author

Gaborit, Benjamin, primary, Dailly, Eric, additional, Vanhove, Bernard, additional, Josien, Régis, additional, Lacombe, Karine, additional, Dubee, Vincent, additional, Ferre, Virginie, additional, Brouard, Sophie, additional, Ader, Florence, additional, Vibet, Marie-Anne, additional, Le Thuaut, Aurélie, additional, Danger, Richard, additional, Flet, Laurent, additional, Omnes, Anne, additional, Berly, Laetitia, additional, Chiffoleau, Anne, additional, Jobert, Alexandra, additional, Duvaux, Odile, additional, and Raffi, François, additional

Published
2021
Full Text
View/download PDF

46. Low levels of respiratory syncytial virus activity in Europe during the 2020/21 season: what can we expect in the coming summer and autumn/winter?

Author

van Summeren, Jojanneke, Meijer, Adam, Aspelund, Guðrún, Casalegno, Jean Sebastien, Erna, Guðrún, Hoang, Uy, Lina, Bruno, de Lusignan, Simon, Teirlinck, Anne C., Thors, Valtýr, Paget, John, Ouziel, Antoine, Tardy, Jean-claude, Gaucherand, Pascal, Massardier, Jerome, Polazzi, Stephanie, Duclos, Antoine, Benchaib, Mehdi, Cartier, Regine, Jourdain, Marine, Ottmann, Michelle, Kramer, Rolf, Fiorini, Sylvie, Rivat, Nathalie, Mekki, Yahia, Fort-Jacquier, Julie, Barral, Maud-Catherine, Noelie, Vey, Haesebaert, Julie, Horvat, Come, Vidoni, Leo, Reynes, Jean-Marc, Eleouet, Jean-Francois, Josset, Laurence, Receveur, Matthieu, Javouhey, Etienne, Ploin, Dominique, Valette, Martine, Fanget, Remi, Targe, Sandrine Couray, Myar-Dury, Anne-Florence, Doret-Dion, Muriel, Massoud, Mona, Masson, Elsa, Bard, Emilie, Queromes, Gregory, Vanhems, Phillipe, Claris, Olivier, Butin, Marine, Ader, Florence, Bin, Sylvie, Gaymard, Alexandre, Morfin, Florence, Gillet, Yves, Netherlands Institute for Health Services Research [Utrecht] (NIVEL), National Institute for Public Health and the Environment [Bilthoven] (RIVM), Directorate of Health [Reykjavík], Institut des Agents Infectieux [Lyon] (IAI), Hospices Civils de Lyon (HCL), Landspitali National University Hospital of Iceland, University of Oxford [Oxford], Children’s Hospital [Reykjavik, Iceland], University of Iceland [Reykjavik], This study is performed as a side project of the RSV ComNet study. The aim of the RSV ComNet project is to measure the disease burden of RSV in children aged ≤5 years in primary care, and is funded by Sanofi Pasteur and AstraZeneca., VRS study group in Lyon: Antoine Ouziel, Jean-claude Tardy, Pascal Gaucherand, Jerome Massardier, Stephanie Polazzi, Antoine Duclos, Mehdi Benchaib, Regine Cartier, Marine Jourdain, Michelle Ottmann, Rolf Kramer, Sylvie Fiorini, Nathalie Rivat, Yahia Mekki, Julie Fort-Jacquier, Maud-Catherine Barral, Vey Noelie, Julie Haesebaert, Come Horvat, Leo Vidoni, Jean-Marc Reynes, Jean-Francois Eleouet, Laurence Josset, Matthieu Receveur, Etienne Javouhey, Dominique Ploin, Martine Valette, Remi Fanget, Sandrine Couray Targe, Anne-Florence Myar-Dury, Muriel Doret-Dion, Mona Massoud, Elsa Masson, Emilie Bard, Gregory Queromes, Phillipe Vanhems, Olivier Claris, Marine Butin, Florence Ader, Sylvie Bin, Alexandre Gaymard, Florence Morfin, Yves Gillet, and Lyon, VRS study group in

Subjects
Author's Correction, 0301 basic medicine, Veterinary medicine, viruses, Iceland, surveillance data, MESH: Respiratory Syncytial Virus, Human, Respiratory syncytial virus, 0302 clinical medicine, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, MESH: Child, Epidemiology, MESH: COVID-19, 030212 general & internal medicine, Respiratory system, Child, virus diseases, RSV, respiratory system, MESH: Iceland, MESH: Infant, Europe, [SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology, epidemiology, France, Seasons, Winter season, Rapid Communication, medicine.medical_specialty, 2019-20 coronavirus outbreak, Surveillance data, Coronavirus disease 2019 (COVID-19), COVID-19 pandemic, Respiratory Syncytial Virus Infections, Biology, Virus, 03 medical and health sciences, MESH: Respiratory Syncytial Virus Infections, Virology, medicine, Humans, MESH: SARS-CoV-2, MESH: Humans, SARS-CoV-2, Public Health, Environmental and Occupational Health, Small children, COVID-19, Infant, MESH: France, 030104 developmental biology, Respiratory Syncytial Virus, Human, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, MESH: Europe, MESH: Seasons
Abstract

International audience; Since the introduction of non-pharmacological interventions to control COVID-19, respiratory syncytial virus (RSV) activity in Europe has been limited. Surveillance data for 17 countries showed delayed RSV epidemics in France (≥ 12 w) and Iceland (≥ 4 w) during the 2020/21 season. RSV cases (predominantly small children) in France and Iceland were older compared with previous seasons. We hypothesise that future RSV epidemic(s) could start outside the usual autumn/winter season and be larger than expected. Year-round surveillance of RSV is of critical importance.

Published
2021

47. Population pharmacokinetics of daptomycin in patients with bone and joint infection: minimal effect of rifampicin co-administration and confirmation of a sex difference

Author

Garreau, Romain, Bricca, Romain, Gagnieu, Marie-Claude, Roux, Sandrine, Conrad, Anne, Bourguignon, Laurent, Ferry, Tristan, Goutelle, Sylvain, Valour, Florent, Perpoint, Thomas, Miailhes, Patrick, Ader, Florence, Becker, Agathe, Triffault-Fillit, Claire, Pouderoux, Cécile, Benech, Nicolas, Chauvelot, Pierre, Perry, Marielle, Daoud, Fatiha, Lippman, Johanna, Braun, Evelyne, Chidiac, Christian, Servien, Elvire, Lustig, Sébastien, Batailler, Cécile, Gunst, Stanislas, Schmidt, Axel, Malatray, Matthieu, Sappey-Marinier, Elliot, Fessy, Michel-Henry, Viste, Anthony, Besse, Jean-Luc, Chaudier, Philippe, Louboutin, Lucie, Ode, Quentin, van Haecke, Adrien, Mercier, Marcelle, Belgaid, Vincent, Walch, Arnaud, Martres, Sébastien, Trouillet, Franck, Barrey, Cédric, Mojallal, Ali, Brosset, Sophie, Hanriat, Camille, Person, Hélène, Sigaux, Nicolas, Céruse, Philippe, Fuchsmann, Carine, Aubrun, Frédéric, Dziadzko, Mikhail, Macabéo, Caroline, Laurent, Frederic, Beraud, Laetitia, Roussel-Gaillard, Tiphaine, Dupieux, Céline, Kolenda, Camille, Josse, Jérôme, Brevet, Marie, Trecourt, Alexis, Craighero, Fabien, Boussel, Loic, Pialat, Jean-Baptiste, Morelec, Isabelle, Tod, Michel, Mabrut, Eugénie, Hospices Civils de Lyon (HCL), Lyon Bone and Joint Infection Study Group (BJI), Hôpital Nord-Ouest de Villefranche-sur-Saône, Service de Maladies Infectieuses et Tropicales [Hôpital de la Croix-Rousse - HCL], Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Centre interrégional de référence Rhône-Alpes - Auvergne des infections ostéo-articulaires complexes, Institut des Sciences Pharmaceutiques et Biologiques (ISPB), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon, Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), Centre International de Recherche en Infectiologie (CIRI), École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre de Recherche en Acquisition et Traitement de l'Image pour la Santé (CREATIS), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Modeling & analysis for medical imaging and Diagnosis (MYRIAD), and Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL)

Subjects
Male, 0301 basic medicine, Microbiology (medical), medicine.medical_specialty, 030106 microbiology, Population, MESH: Daptomycin, 03 medical and health sciences, 0302 clinical medicine, Daptomycin, Pharmacokinetics, MESH: Drug Monitoring, Internal medicine, MESH: Anti-Bacterial Agents, medicine, polycyclic compounds, Humans, Pharmacology (medical), 030212 general & internal medicine, Dosing, education, Pharmacology, Volume of distribution, Sex Characteristics, education.field_of_study, MESH: Humans, medicine.diagnostic_test, business.industry, Drug interaction, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, bacterial infections and mycoses, MESH: Rifampin, MESH: Male, Anti-Bacterial Agents, Infectious Diseases, Therapeutic drug monitoring, Female, Drug Monitoring, Rifampin, business, MESH: Female, Rifampicin, medicine.drug, MESH: Sex Characteristics
Abstract

Background Daptomycin is increasingly used in the treatment of bone and joint infection (BJI), but its pharmacokinetics (PK) and dosage requirements have not been thoroughly investigated in this indication. Daptomycin may be co-administered with rifampicin, which raises questions about a potential drug interaction. Objectives To investigate the population PK and dosage requirements of daptomycin in patients with BJI, and examine the influence of rifampicin co-administration. Methods A population approach was used to analyse PK data from patients who received daptomycin in our regional reference for BJI. We examined the influence of available covariates, including rifampicin co-administration on daptomycin PK. Simulations performed with the final model investigated the influence of dosages and covariates on PTA for both efficacy and safety. Results A total of 1303 daptomycin concentrations from 183 patients were analysed. A two-compartment model best described the data. Significant intra-individual variability was observed. Daptomycin clearance was influenced by renal function and sex, with females having a 26% lower typical clearance than males. Central volume of distribution (V1) was influenced by body weight, age, sex and rifampicin co-administration. Typical V1 was 11% lower in patients who were co-administered rifampicin. In PK/PD simulations, sex influenced the probability of AUC24/MIC target attainment, while rifampicin had a marginal effect. Conclusions A daptomycin dosage of 8 mg/kg/24 h in women and 10 mg/kg/24 h in men should optimize efficacy but may lead to excessive trough concentrations in many patients, especially in women. Therapeutic drug monitoring appears necessary for precision dosing of daptomycin.

Published
2021

48. Relevance of QuantiFERON-TB Gold Plus and Heparin-Binding Hemagglutinin Interferon-γ Release Assays for Monitoring of Pulmonary Tuberculosis Clearance: A Multicentered Study

Author

Chedid, Carole, Kokhreidze, Eka, Tukvadze, Nestani, Banu, Sayera, Uddin, Mohammad Khaja Mafij, Biswas, Samanta, Russomando, Graciela, Acosta, Chyntia Carolina Díaz, Arenas, Rossana, Ranaivomanana, Paulo PR., Razafimahatratra, Crisca, Herindrainy, Perlinot, Rakotonirina, Julio, Raherinandrasana, Antso Hasina, Rakotosamimanana, Niaina, Hamze, Monzer, Ismail, Mohamad Bachar, Bayaa, Rim, Berland, Jean-Luc, De Maio, Flavio, Delogu, Giovanni, Endtz, Hubert, Ader, Florence, Goletti, Delia, and Hoffmann, Jonathan

Subjects
Adult, Male, Immunology, Antitubercular Agents, Enzyme-Linked Immunosorbent Assay, inflammatory markers, QuantiFERON, Cohort Studies, heparin-binding haemagglutinin adhesin, treatment monitoring, Interferon-gamma, Treatment Outcome, tuberculosis, immunomonitoring, Latent Tuberculosis, Humans, Immunology and Allergy, Female, Tuberculosis, Pulmonary, Biomarkers, Original Research, interferon-gamma release assays
Abstract

Background Tuberculosis (TB) is a leading infectious cause of death. To improve treatment efficacy, quicker monitoring methods are needed. The objective of this study was to monitor the response to a heparin-binding hemagglutinin (HBHA) interferon-γ (IFN-γ) release assay (IGRA) and QuantiFERON-TB Gold Plus (QFT-P) and to analyze plasma IFN-γ levels according to sputum culture conversion and immune cell counts during treatment. Methods This multicentered cohort study was based in Bangladesh, Georgia, Lebanon, Madagascar, and Paraguay. Adult, non-immunocompromised patients with culture-confirmed pulmonary TB were included. Patients were followed up at baseline (T0), after two months of treatment (T1), and at the end of therapy (T2). Clinical data and blood samples were collected at each timepoint. Whole blood samples were stimulated with QFT-P antigens or recombinant methylated Mycobacterium tuberculosis HBHA (produced in Mycobacterium smegmatis; rmsHBHA). Plasma IFN-γ levels were then assessed by ELISA. Findings Between December 2017 and September 2020, 132 participants completed treatment, including 28 (21.2%) drug-resistant patients. rmsHBHA IFN-γ increased significantly throughout treatment (0.086 IU/ml at T0 vs. 1.03 IU/ml at T2, p < 0.001) while QFT-P IFN-γ remained constant (TB1: 0.53 IU/ml at T0 vs. 0.63 IU/ml at T2, p = 0.13). Patients with low lymphocyte percentages (79%) at baseline had significantly lower IFN-γ responses to QFT-P and rmsHBHA at T0 and T1. In a small group of slow converters (patients with positive cultures at T1; n = 16), we observed a consistent clinical pattern at baseline (high neutrophil percentages, low lymphocyte percentages and BMI, low TB1, TB2, and MIT IFN-γ responses) and low rmsHBHA IFN-γ at T1 and T2. However, the accuracy of the QFT-P and rmsHBHA IGRAs compared to culture throughout treatment was low (40 and 65% respectively). Combining both tests improved their sensitivity and accuracy (70–80%) but not their specificity (

Published
2021
Full Text
View/download PDF

49. Rifampicin exposure reveals within-host Mycobacterium tuberculosis diversity in patients with delayed culture conversion

Author

Genestet, Charlotte, primary, Hodille, Elisabeth, additional, Barbry, Alexia, additional, Berland, Jean-Luc, additional, Hoffmann, Jonathan, additional, Westeel, Emilie, additional, Bastian, Fabiola, additional, Guichardant, Michel, additional, Venner, Samuel, additional, Lina, Gérard, additional, Ginevra, Christophe, additional, Ader, Florence, additional, Goutelle, Sylvain, additional, and Dumitrescu, Oana, additional

Published
2021
Full Text
View/download PDF

50. Interferon-[gamma] autoantibodies as predisposing factor for nontuberculous mycobacterial infection

Author

Valour, Florent, Perpoint, Thomas, Senechal, Agathe, Kong, Xiao-Fei, Bustamante, Jacinta, Ferry, Tristan, Chidiac, Christian, and Ader, Florence

Subjects
Bacterial infections -- Health aspects, Biological response modifiers -- Health aspects, Autoimmunity -- Health aspects, Autoantibodies -- Health aspects, Health
Abstract

Letter to the Editor To the Editor: Recent advances in the understanding of antimycobacterial immune response have led to descriptions of predisposing conditions to dissemination of nontuberculous mycobacteria (NTM) infection. [...]

Published
2016

Catalog

Books, media, physical & digital resources
See catalog results