Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients (DAFNE)

Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients (DAFNE Study)

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).

Study Overview

• Status: Completed
• Conditions: Clostridium Difficile Infection
• Intervention / Treatment: Drug: Fidaxomicin; Drug: Treatment for CDI other than fidaxomicin Type

• Study Type: Observational
• Enrollment (Actual): 296

Contacts and Locations

Study Locations

• France
  • Bethune, France
    • Site
  • Bordeaux, France
    • Site
  • Boulogne Billancourt, France
    • Site
  • Caen Cedex 9, France
    • Site
  • Chambéry, France
    • Site
  • Clermond-Ferrand, France
    • Site
  • Clichy, France
    • Site
  • Dijon, France
    • Site
  • Garches, France
    • Site
  • La Tronche, France
    • Site
  • Lille, France
    • Site
  • Lyon, France
    • Site
  • Marseille, France
    • Site
  • Morlaix, France
    • Site
  • Mulhouse, France
    • Site
  • Nantes, France
    • Site
  • Nimes, France
    • Site
  • Orléans Cedex 2, France
    • Site
  • Paris, France
    • Site
  • Poitiers, France
    • Site
  • Reims, France
    • Site
  • Rennes Cedex, France
    • Site
  • Roubaix Cedex 1, France
    • Site
  • Soissons, France
    • Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult hospitalized patients diagnosed with clostridium difficile infection

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1: CDI in patients treated with fidaxomicin; Diagnosed with a CDI and treated with fidaxomicin	Drug: Fidaxomicin; oral; Other Names: Dificid; ASP2819; Dificlir
2: CDI in patients receiving treatment other than fidaxomicin; Diagnosed with a CDI, regardless of the prescribed treatment (not fidaxomicin)	Drug: Treatment for CDI other than fidaxomicin Type; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Characteristics of patients treated with fidaxomicin, including demographic data, description of comorbidities and treatment by antibiotherapy	Day 1
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	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic management of the CDI, including the starting date of the treatment, CDI treatment first line and associated treatment	For patients treated with fidaxomicin	Day 1
Number and timing of recurrences in patients treated with fidaxomicin over a 3-month follow-up period		End of the follow-up (3 months)
Adverse events and serious adverse events occurring on fidaxomicin		End of the follow-up (3 months)
Characteristics of patients diagnosed with CDI, including demographic data and treatment by antibiotherapy	For all patients diagnosed with CDI regardless of treatment	Day 1
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	For all patients diagnosed with CDI regardless of treatment	Day 1
Treatment of the CDI including treatment selected and dosage	For all patients diagnosed with CDI regardless of treatment	Day 1

Collaborators and Investigators

• Sponsor: Astellas Pharma S.A.S.
• Investigators: Study Director: Medical and Scientific Affairs manager, Astellas Pharma S.A.S.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2014
• Primary Completion (Actual): March 27, 2017
• Study Completion (Actual): August 17, 2017

Study Registration Dates

• First Submitted: May 13, 2014
• First Submitted That Met QC Criteria: August 11, 2014
• First Posted (Estimate): August 12, 2014

Study Record Updates

• Last Update Posted (Actual): October 12, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Observational; Clostridium difficile infection CDI; Fidaxomicin recurrence; France
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Clostridium Infections; Anti-Infective Agents; Anti-Bacterial Agents; Fidaxomicin
• Other Study ID Numbers: FR-FID-NI-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No