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

Benoit Guery, Pierre Berger, Remy Gauzit, Magali Gourdon, Frédéric Barbut, DAFNE study group, Dafne Study Group, Pascale Bémer, Emilie Bessède, Fabrice Camou, Vincent Cattoir, Carine Couzigou, Dominique Descamps, Aurélien Dinh, Caroline Laurans, Jean-Philippe Lavigne, Catherine Lechiche, Véronique Leflon-Guibout, Alban Le Monnier, Marion Levast, Joy Yoganaden Mootien, Yohan N'Guyen, Lionel Piroth, Thierry Prazuck, Olivier Rogeaux, Anne-Laure Roux, Anne Vachée, Véronique Vernet Garnier, Frédéric Wallet, Benoit Guery, Pierre Berger, Remy Gauzit, Magali Gourdon, Frédéric Barbut, DAFNE study group, Dafne Study Group, Pascale Bémer, Emilie Bessède, Fabrice Camou, Vincent Cattoir, Carine Couzigou, Dominique Descamps, Aurélien Dinh, Caroline Laurans, Jean-Philippe Lavigne, Catherine Lechiche, Véronique Leflon-Guibout, Alban Le Monnier, Marion Levast, Joy Yoganaden Mootien, Yohan N'Guyen, Lionel Piroth, Thierry Prazuck, Olivier Rogeaux, Anne-Laure Roux, Anne Vachée, Véronique Vernet Garnier, Frédéric Wallet

Abstract

Objective: To describe the characteristics, management and outcomes of hospitalised patients with Clostridioides difficile infection (CDI) treated with and without fidaxomicin.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: Clostridioides (Clostridium) difficile; antibiotic usage; clinical; fidaxomicin; infection; real-world setting.

Conflict of interest statement

Declaration of conflicting interest: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: FB reports personal fees from Pfizer, MSD and Sanofi Pasteur; non-financial support from Astellas Pharma Inc, Pfizer, Anios and MSD; and grants from Anios, MSD, Biomerieux, Quidel, Diasorin, Cubist, Biosynex, GenePOC, Cepheid and Sanofi Pasteur.

BG reports non-financial support from Astellas Pharma Inc and grants from Pfizer and MSD.

MG is a full-time employee of Astellas Pharma S.A.S.

PB received personal fees from Astellas Pharma Inc and Pfizer.

RG reports non-financial support from Astellas Pharma Inc and personal fees from Sanofi, Correvio, MSD, Pfizer, Eumedica and Frezenius.

Figures

Figure 1.
Figure 1.
Patient flow through the study. C. difficile, Clostridioides difficile; CDI, Clostridioides difficile infection; N, number of patients.
Figure 2.
Figure 2.
HRQOL (EQ-5D-5L) scores at baseline and the 3-month follow-up in the main analysis (fidaxomicin-treated) populationa. aData from the EQ-5D-5L questionnaire were available for 176 patients at the time of CDI diagnosis and 105 patients at the 3-month follow-up. CDI, Clostridioides difficile infection; EQ-5D-5L, HRQoL was assessed using the EQ-5D-5L questionnaire, which included five domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression); HRQOL, health-related quality of life; N, number of patients with information available.

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