Clinical trial NCT02214771: Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients
Official title: Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients (DAFNE Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clostridium Difficile Infection
Keywords: Clostridium difficile infection CDI
Observational
Fidaxomicin recurrence
France
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-08-12
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult hospitalized patients diagnosed with clostridium difficile infection

Brief summary: The study aims to describe the characteristics and the methods of management and follow-up of patients treated with fidaxomicin for Clostridium difficile infection (CDI).


Eligibility criteria: Inclusion Criteria:

* Hospitalized patient
* Patient diagnosed with CDI

Exclusion Criteria:

* Patient already included in this study
* Patient is taking part in a clinical trial in the field of CDI

Primary outcomes:
measure: Characteristics of patients treated with fidaxomicin, including demographic data, description of comorbidities and treatment by antibiotherapy
timeFrame: Day 1
measure: Characteristics of the CDI treated with fidaxomicin, including date of CDI diagnosis, department requesting the diagnosis of CDI, methods used, severity of CDI and origin of the case
timeFrame: Day 1
Secondary outcomes:
measure: Therapeutic management of the CDI, including the starting date of the treatment, CDI treatment first line and associated treatment
timeFrame: Day 1
measure: Number and timing of recurrences in patients treated with fidaxomicin over a 3-month follow-up period
timeFrame: End of the follow-up (3 months)
measure: Adverse events and serious adverse events occurring on fidaxomicin
timeFrame: End of the follow-up (3 months)
measure: Characteristics of patients diagnosed with CDI, including demographic data and treatment by antibiotherapy
timeFrame: Day 1
measure: Characteristics of the CDI, including date of CDI diagnosis, Department requesting the diagnosis of CDI, methods used, severity of CDI and origin of the case
timeFrame: Day 1
measure: Treatment of the CDI including treatment selected and dosage
timeFrame: Day 1
Other outcomes:
Locations:
city: Bethune
country: France
facility: Site
city: Bordeaux
country: France
facility: Site
city: Boulogne Billancourt
country: France
facility: Site
city: Caen Cedex 9
country: France
facility: Site
city: Chambéry
country: France
facility: Site
city: Clermond-Ferrand
country: France
facility: Site
city: Clichy
country: France
facility: Site
city: Dijon
country: France
facility: Site
city: Garches
country: France
facility: Site
city: La Tronche
country: France
facility: Site
city: Lille
country: France
facility: Site
city: Lyon
country: France
facility: Site
city: Marseille
country: France
facility: Site
city: Morlaix
country: France
facility: Site
city: Mulhouse
country: France
facility: Site
city: Nantes
country: France
facility: Site
city: Nimes
country: France
facility: Site
city: Orléans Cedex 2
country: France
facility: Site
city: Paris
country: France
facility: Site
city: Poitiers
country: France
facility: Site
city: Reims
country: France
facility: Site
city: Rennes Cedex
country: France
facility: Site
city: Roubaix Cedex 1
country: France
facility: Site
city: Soissons
country: France
facility: Site
Study officials:
affiliation: Astellas Pharma S.A.S.
name: Medical and Scientific Affairs manager
role: STUDY_DIRECTOR
References:
citation: Guery B, Berger P, Gauzit R, Gourdon M, Barbut F; DAFNE study group; Dafne Study Group, Bemer P, Bessede E, Camou F, Cattoir V, Couzigou C, Descamps D, Dinh A, Laurans C, Lavigne JP, Lechiche C, Leflon-Guibout V, Le Monnier A, Levast M, Mootien JY, N'Guyen Y, Piroth L, Prazuck T, Rogeaux O, Roux AL, Vachee A, Vernet Garnier V, Wallet F. A prospective, observational study of fidaxomicin use for Clostridioides difficile infection in France. J Int Med Res. 2021 Jun;49(6):3000605211021278. doi: 10.1177/03000605211021278.