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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02214771

Acronym

DAFNE

Enrollment

296

Registered

2014-08-12

Start date

2014-09-03

Completion date

2017-08-17

Last updated

2017-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Difficile Infection

Keywords

Clostridium difficile infection CDI, Observational, Fidaxomicin recurrence, France

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).

Interventions

DRUGFidaxomicin

oral

DRUGTreatment for CDI other than fidaxomicin Type

Oral

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Measure	Time frame	Description
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	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
Treatment of the CDI including treatment selected and dosage	Day 1	For all patients diagnosed with CDI regardless of treatment
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
Number and timing of recurrences in patients treated with fidaxomicin over a 3-month follow-up period	End of the follow-up (3 months)	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026