PMID- 34162264
OWN - NLM
STAT- MEDLINE
DCOM- 20210625
LR  - 20210709
IS  - 1473-2300 (Electronic)
IS  - 0300-0605 (Print)
IS  - 0300-0605 (Linking)
VI  - 49
IP  - 6
DP  - 2021 Jun
TI  - A prospective, observational study of fidaxomicin use for Clostridioides 
      difficile infection in France.
PG  - 3000605211021278
LID - 10.1177/03000605211021278 [doi]
LID - 03000605211021278
AB  - 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.
FAU - Guery, Benoit
AU  - Guery B
AUID- ORCID: 0000-0002-6526-0714
AD  - University Hospital and University of Lausanne, Lausanne, Switzerland.
FAU - Berger, Pierre
AU  - Berger P
AD  - Paoli-Calmettes Institute, Marseille, France.
FAU - Gauzit, Remy
AU  - Gauzit R
AD  - Cochin University Hospital, Paris, France.
FAU - Gourdon, Magali
AU  - Gourdon M
AD  - Astellas Pharma S.A.S., Levallois-Perret, France.
FAU - Barbut, Frederic
AU  - Barbut F
AD  - National Reference Laboratory for C. difficile, Saint-Antoine Hospital, Paris, 
      France.
AD  - INSERM S-1139, Faculty of Pharmacy, University of Paris, Paris, France.
CN  - DAFNE study group
FAU - Dafne Study Group
AU  - Dafne Study Group
FAU - Bemer, Pascale
AU  - Bemer P
FAU - Bessede, Emilie
AU  - Bessede E
FAU - Camou, Fabrice
AU  - Camou F
FAU - Cattoir, Vincent
AU  - Cattoir V
FAU - Couzigou, Carine
AU  - Couzigou C
FAU - Descamps, Dominique
AU  - Descamps D
FAU - Dinh, Aurelien
AU  - Dinh A
FAU - Laurans, Caroline
AU  - Laurans C
FAU - Lavigne, Jean-Philippe
AU  - Lavigne JP
FAU - Lechiche, Catherine
AU  - Lechiche C
FAU - Leflon-Guibout, Veronique
AU  - Leflon-Guibout V
FAU - Le Monnier, Alban
AU  - Le Monnier A
FAU - Levast, Marion
AU  - Levast M
FAU - Mootien, Joy Yoganaden
AU  - Mootien JY
FAU - N'Guyen, Yohan
AU  - N'Guyen Y
FAU - Piroth, Lionel
AU  - Piroth L
FAU - Prazuck, Thierry
AU  - Prazuck T
FAU - Rogeaux, Olivier
AU  - Rogeaux O
FAU - Roux, Anne-Laure
AU  - Roux AL
FAU - Vachee, Anne
AU  - Vachee A
FAU - Vernet Garnier, Veronique
AU  - Vernet Garnier V
FAU - Wallet, Frederic
AU  - Wallet F
LA  - eng
SI  - ClinicalTrials.gov/NCT02214771
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PL  - England
TA  - J Int Med Res
JT  - The Journal of international medical research
JID - 0346411
RN  - 0 (Aminoglycosides)
RN  - 0 (Anti-Bacterial Agents)
RN  - 6Q205EH1VU (Vancomycin)
RN  - Z5N076G8YQ (Fidaxomicin)
SB  - IM
MH  - Aminoglycosides/adverse effects
MH  - Anti-Bacterial Agents/adverse effects
MH  - Clostridioides
MH  - *Clostridioides difficile
MH  - *Clostridium Infections/drug therapy
MH  - Fidaxomicin
MH  - France
MH  - Humans
MH  - Prospective Studies
MH  - Vancomycin
PMC - PMC8236878
OTO - NOTNLM
OT  - Clostridioides (Clostridium) difficile
OT  - antibiotic usage
OT  - clinical
OT  - fidaxomicin
OT  - infection
OT  - real-world setting
COIS- 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.
EDAT- 2021/06/25 06:00
MHDA- 2021/06/29 06:00
PMCR- 2021/06/23
CRDT- 2021/06/24 05:27
PHST- 2021/06/24 05:27 [entrez]
PHST- 2021/06/25 06:00 [pubmed]
PHST- 2021/06/29 06:00 [medline]
PHST- 2021/06/23 00:00 [pmc-release]
AID - 10.1177_03000605211021278 [pii]
AID - 10.1177/03000605211021278 [doi]
PST - ppublish
SO  - J Int Med Res. 2021 Jun;49(6):3000605211021278. doi: 10.1177/03000605211021278.