NCT02214771

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
296

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

September 3, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2017

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

2.6 years

First QC Date

May 13, 2014

Last Update Submit

October 11, 2017

Conditions

Clostridium Difficile Infection

Keywords

Clostridium difficile infection CDIObservationalFidaxomicin recurrenceFrance

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Therapeutic management of the CDI, including the starting date of the treatment, CDI treatment first line and associated treatment

    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

    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

    Day 1

  • +1 more secondary outcomes

Study Arms (2)

1: CDI in patients treated with fidaxomicin

Diagnosed with a CDI and treated with fidaxomicin

Drug: Fidaxomicin

2: CDI in patients receiving treatment other than fidaxomicin

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

Drug: Treatment for CDI other than fidaxomicin Type

Interventions

FidaxomicinDRUG

oral

Also known as: Dificid, ASP2819, Dificlir
1: CDI in patients treated with fidaxomicin
Treatment for CDI other than fidaxomicin TypeDRUG

Oral

2: CDI in patients receiving treatment other than fidaxomicin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult hospitalized patients diagnosed with clostridium difficile infection

You may qualify if:

  • Hospitalized patient
  • Patient diagnosed with CDI

You may not qualify if:

  • Patient already included in this study
  • Patient is taking part in a clinical trial in the field of CDI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Site

Béthune, France

Location

Site

Bordeaux, France

Location

Site

Boulogne-Billancourt, France

Location

Site

Caen, France

Location

Site

Chambéry, France

Location

Site

Clermond-Ferrand, France

Location

Site

Clichy, France

Location

Site

Dijon, France

Location

Site

Garches, France

Location

Site

La Tronche, France

Location

Site

Lille, France

Location

Site

Lyon, France

Location

Site

Marseille, France

Location

Site

Morlaix, France

Location

Site

Mulhouse, France

Location

Site

Nantes, France

Location

Site

Nîmes, France

Location

Site

Orléans, France

Location

Site

Paris, France

Location

Site

Poitiers, France

Location

Site

Reims, France

Location

Site

Rennes, France

Location

Site

Roubaix, France

Location

Site

Soissons, France

Location

Related Publications (1)

  • 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.

    PMID: 34162264DERIVED

MeSH Terms

Conditions

Clostridium Infections

Interventions

FidaxomicinTherapeutics

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsPolyketidesMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Medical and Scientific Affairs manager

    Astellas Pharma S.A.S.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2014

First Posted

August 12, 2014

Study Start

September 3, 2014

Primary Completion

March 27, 2017

Study Completion

August 17, 2017

Last Updated

October 12, 2017

Record last verified: 2017-10

Locations

FR(24)