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Article Dans Une Revue Journal of International Medical Research Année : 2021

A prospective, observational study of fidaxomicin use for Clostridioides difficile infection in France

Pascale Bémer
  • Fonction : Auteur
Emilie Bessède
  • Fonction : Auteur
Fabrice Camou
  • Fonction : Auteur
Vincent Cattoir
  • Fonction : Auteur
Carine Couzigou
  • Fonction : Auteur
Dominique Descamps
  • Fonction : Auteur
Aurélien Dinh
  • Fonction : Auteur
Caroline Laurans
  • Fonction : Auteur
Jean-Philippe Lavigne
  • Fonction : Auteur
Catherine Lechiche
  • Fonction : Auteur
Véronique Leflon-Guibout
  • Fonction : Auteur
Marion Levast
  • Fonction : Auteur
Joy Yoganaden Mootien
  • Fonction : Auteur
Yohan N’guyen
  • Fonction : Auteur
Lionel Piroth
  • Fonction : Auteur
Thierry Prazuck
  • Fonction : Auteur
Olivier Rogeaux
  • Fonction : Auteur
Anne-Laure Roux
  • Fonction : Auteur
Anne Vachée
  • Fonction : Auteur
Véronique Vernet Garnier
  • Fonction : Auteur
Frédéric Wallet
  • Fonction : Auteur

Résumé

To describe the characteristics, management and outcomes of hospitalised patients with Clostridioides difficile infection (CDI) treated with and without fidaxomicin. This prospective, multicentre, observational study (DAFNE) enrolled hospitalised patients with CDI, including 294 patients treated with fidaxomicin (outcomes recorded over a 3-month period) and 150 patients treated with other CDI therapies during three 1-month periods. The primary endpoint was baseline and CDI characteristics of fidaxomicin-treated patients. At baseline, the fidaxomicin-treated population included immunocompromised patients (39.1%) and patients with severe (59.2%) and recurrent (36.4%) CDI. Fidaxomicin was associated with a high rate of clinical cure (92.2%) and low CDI recurrence (16.3% within 3 months). Clinical cure rates were ≥90% in patients aged ≥65 years, those receiving concomitant antibiotics and those with prior or severe CDI. There were 121/296 (40.9%) patients with adverse events (AEs), 5.4% with fidaxomicin-related AEs and 1.0% with serious fidaxomicin-related AEs. No fidaxomicin-related deaths were reported. Fidaxomicin is an effective and well-tolerated CDI treatment in a real-world setting in France, which included patients at high risk of adverse outcomes. Trial registration: Description of the use of fidaxomicin in hospitalised patients with documented Clostridium difficile infection and the management of these patients (DAFNE), NCT02214771, www.ClinicalTrials.gov.

Dates et versions

hal-04096886 , version 1 (13-05-2023)

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Benoit Guery, Pierre Berger, Remy Gauzit, Magali Gourdon, Frédéric Barbut, et al.. A prospective, observational study of fidaxomicin use for Clostridioides difficile infection in France. Journal of International Medical Research, 2021, 49 (6), pp. 030006052110212. ⟨10.1177/03000605211021278⟩. ⟨hal-04096886⟩
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