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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

NCT ID: NCT02214771

Last Updated: 2017-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

296 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-03

Study Completion Date

2017-08-17

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).

Detailed Description

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Conditions

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Clostridium Difficile Infection

Keywords

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Clostridium difficile infection CDI Observational Fidaxomicin recurrence France

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1: CDI in patients treated with fidaxomicin

Diagnosed with a CDI and treated with fidaxomicin

Fidaxomicin

Intervention Type DRUG

oral

2: CDI in patients receiving treatment other than fidaxomicin

Diagnosed with a CDI, regardless of the prescribed treatment (not fidaxomicin)

Treatment for CDI other than fidaxomicin Type

Intervention Type DRUG

Oral

Interventions

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Fidaxomicin

oral

Intervention Type DRUG

Treatment for CDI other than fidaxomicin Type

Oral

Intervention Type DRUG

Other Intervention Names

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Dificid ASP2819 Dificlir

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma S.A.S.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical and Scientific Affairs manager

Role: STUDY_DIRECTOR

Astellas Pharma S.A.S.

Locations

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Béthune, , France

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Bordeaux, , France

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Boulogne-Billancourt, , France

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Caen, , France

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Chambéry, , France

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Clermond-Ferrand, , France

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Clichy, , France

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Dijon, , France

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Garches, , France

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La Tronche, , France

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Lille, , France

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Lyon, , France

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Marseille, , France

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Morlaix, , France

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Mulhouse, , France

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Nantes, , France

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Nîmes, , France

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Orléans, , France

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Paris, , France

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Poitiers, , France

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Reims, , France

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Rennes, , France

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Roubaix, , France

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Soissons, , France

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Countries

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France

References

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Guery B, Berger P, Gauzit R, Gourdon M, Barbut F; DAFNE study group; Dafne Study Group, Bemer P, Bessede E, Camou F, Cattoir V, Couzigou C, Descamps D, Dinh A, Laurans C, Lavigne JP, Lechiche C, Leflon-Guibout V, Le Monnier A, Levast M, Mootien JY, N'Guyen Y, Piroth L, Prazuck T, Rogeaux O, Roux AL, Vachee A, Vernet Garnier V, Wallet F. A prospective, observational study of fidaxomicin use for Clostridioides difficile infection in France. J Int Med Res. 2021 Jun;49(6):3000605211021278. doi: 10.1177/03000605211021278.

Reference Type DERIVED
PMID: 34162264 (View on PubMed)

Other Identifiers

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FR-FID-NI-001

Identifier Type: -

Identifier Source: org_study_id