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

Details

Serval ID
serval:BIB_8FC65075C2F5
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
A prospective, observational study of fidaxomicin use for Clostridioides difficile infection in France.
Journal
The Journal of international medical research
Author(s)
Guery B., Berger P., Gauzit R., Gourdon M., Barbut F., Dafne Study Group -, Bémer P., Bessède E., Camou F., Cattoir V., Couzigou C., Descamps D., Dinh A., Laurans C., Lavigne J.P., Lechiche C., Leflon-Guibout V., Le Monnier A., Levast M., Mootien J.Y., N'Guyen Y., Piroth L., Prazuck T., Rogeaux O., Roux A.L., Vachée A., Vernet Garnier V., Wallet F.
Working group(s)
DAFNE study group
ISSN
1473-2300 (Electronic)
ISSN-L
0300-0605
Publication state
Published
Issued date
06/2021
Peer-reviewed
Oui
Volume
49
Number
6
Pages
3000605211021278
Language
english
Notes
Publication types: Journal Article ; Multicenter Study ; Observational Study
Publication Status: ppublish
Abstract
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.
Keywords
Aminoglycosides/adverse effects, Anti-Bacterial Agents/adverse effects, Clostridioides, Clostridioides difficile, Clostridium Infections/drug therapy, Fidaxomicin, France, Humans, Prospective Studies, Vancomycin, Clostridioides (Clostridium) difficile, antibiotic usage, clinical, fidaxomicin, infection, real-world setting
Pubmed
Open Access
Yes
Create date
06/07/2021 15:36
Last modification date
09/07/2021 6:37
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