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

Condition(s) targeted: Clostridium Difficile Infection

Intervention: Fidaxomicin (Drug); Treatment for CDI other than fidaxomicin Type (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Astellas Pharma S.A.S.

Official(s) and/or principal investigator(s):
Medical and Scientific Affairs manager, Study Director, Affiliation: Astellas Pharma S.A.S.

Overall contact:
Medical Department Infectiology Department, Phone: + 31 (0)71 545050, Email: Astellas.registration@astellas.com

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).

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 design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Characteristics of patients treated with fidaxomicin, including demographic data, description of comorbidities and treatment by antibiotherapy

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

Secondary outcome:

Therapeutic management of the CDI, including the starting date of the treatment, CDI treatment first line and associated treatment

Number and timing of recurrences in patients treated with fidaxomicin over a 3-month follow-up period

Adverse events and serious adverse events occurring on fidaxomicin

Characteristics of patients diagnosed with CDI, including demographic data and treatment by antibiotherapy

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

Treatment of the CDI including treatment selected and dosage

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Medical Department Infectiology Department, Phone: + 31 (0)71 545050, Email: Astellas.registration@astellas.com

Ch Bethune, Bethune, France; Recruiting

Centre Hospitalier, Bordeaux, France; Active, not recruiting

Hopital Ambroise Pare, Boulogne Billancourt, France; Active, not recruiting

Chru de Caen, Caen Cedex 9, France; Recruiting

CH Chambéry, Chambéry, France; Recruiting

CHRU Clermont Ferrand, Clermond-Ferrand, France; Recruiting

Hopital Beaujon, Clichy, France; Active, not recruiting

CHU, Dijon, France; Active, not recruiting

Hopital Raymond Poincare, Garches, France; Active, not recruiting

Chu de Grenoble, La Tronche, France; Recruiting

Centre Hospitalier, Lens, France; Active, not recruiting

CHRU Lille, Lille, France; Recruiting

Hopital de La Croix Rousse, Lyon, France; Recruiting

Institut Paoli Calmettes, Marseille, France; Recruiting

Hopital Mercy, Metz, France; Recruiting

Ch de Morlaix, Morlaix, France; Recruiting

Ch Mulhouse, Mulhouse, France; Recruiting

Chru de Nantes, Nantes, France; Recruiting

Chu Caremeau, Nimes, France; Recruiting

Chro - Hopital de La Source, Orléans Cedex 2, France; Recruiting

Gh Broca La Rochefoucauld La Collegiale, Paris, France; Active, not recruiting

Hopital Saint Antoine, Paris, France; Recruiting

Hopital Saint Joseph, Paris, France; Recruiting

Chru Poitiers, Poitiers, France; Recruiting

Chu Robert Debre, Reims, France; Active, not recruiting

Chru Pontchaillou, Rennes Cedex, France; Recruiting

Ch de Roubaix, Roubaix Cedex 1, France; Recruiting

Ch de Soissons, Soissons, France; Recruiting

Starting date: September 2014
Last updated: July 30, 2015