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

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

Conditions
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Clostridium Difficile Infection

Intervention / Treatment
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* Drug: Fidaxomicin
* Drug: Treatment for CDI other than fidaxomicin Type


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1: CDI in patients treated with fidaxomicin<br>Diagnosed with a CDI and treated with fidaxomicin | Drug: Fidaxomicin<br>* oral<br>* Other names: Dificlir;|
| 2: CDI in patients receiving treatment other than fidaxomicin<br>Diagnosed with a CDI, regardless of the prescribed treatment (not fidaxomicin) | Drug: Treatment for CDI other than fidaxomicin Type<br>* Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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France, Clostridium difficile infection CDI, Observational, Fidaxomicin recurrence