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

Completed

• Conditions: Clostridium Difficile Infection
• Interventions: Drug: Treatment for CDI other than fidaxomicin Type; Drug: Fidaxomicin

• Registration Number: NCT02214771
• Lead Sponsor: Astellas Pharma S.A.S.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-08-11
• Study First Posted: 2014-08-12
• Study Start: 2014-09-03
• Primary Completion: 2017-03-27
• Study Completion: 2017-08-17
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 296

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2: CDI in patients receiving treatment other than fidaxomicin	Treatment for CDI other than fidaxomicin Type	Diagnosed with a CDI, regardless of the prescribed treatment (not fidaxomicin)
1: CDI in patients treated with fidaxomicin	Fidaxomicin	Diagnosed with a CDI and treated with fidaxomicin

Primary Outcome Measures

Name	Time	Method
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
Characteristics of patients treated with fidaxomicin, including demographic data, description of comorbidities and treatment by antibiotherapy	Day 1

Secondary Outcome Measures

Name	Time	Method
Characteristics of patients diagnosed with CDI, including demographic data and treatment by antibiotherapy	Day 1	For all patients diagnosed with CDI regardless of treatment
Therapeutic management of the CDI, including the starting date of the treatment, CDI treatment first line and associated treatment	Day 1	For patients treated with fidaxomicin
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 the CDI, including date of CDI diagnosis, Department requesting the diagnosis of CDI, methods used, severity of CDI and origin of the case	Day 1	For all patients diagnosed with CDI regardless of treatment
Treatment of the CDI including treatment selected and dosage	Day 1	For all patients diagnosed with CDI regardless of treatment

Trial Locations

Locations (1)

Site; 🇫🇷 Soissons, France