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

Clostridium Difficile Infection Clinical Trial

— DAFNE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02214771
• Other study ID #: FR-FID-NI-001
• Status: Completed
• Phase: N/A
• First received: May 13, 2014
• Last updated: October 11, 2017
• Start date: September 3, 2014
• Est. completion date: August 17, 2017

Study information

• Verified date: October 2017
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: August 17, 2017
• Est. primary completion date: March 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Communicable Diseases
• Infection

Intervention

Drug:
• Fidaxomicin
oral
• Treatment for CDI other than fidaxomicin Type
Oral

Locations

Country	Name	City	State
France	Site	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

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma S.A.S.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characteristics of patients treated with fidaxomicin, including demographic data, description of comorbidities and treatment by antibiotherapy		Day 1
Primary	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	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
Secondary	Number and timing of recurrences in patients treated with fidaxomicin over a 3-month follow-up period		End of the follow-up (3 months)
Secondary	Adverse events and serious adverse events occurring on fidaxomicin		End of the follow-up (3 months)
Secondary	Characteristics of patients diagnosed with CDI, including demographic data and treatment by antibiotherapy	For all patients diagnosed with CDI regardless of treatment	Day 1
Secondary	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
Secondary	Treatment of the CDI including treatment selected and dosage	For all patients diagnosed with CDI regardless of treatment	Day 1