We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02214771
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( 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).

Condition or disease Intervention/treatment
Clostridium Difficile Infection Drug: Fidaxomicin Drug: Treatment for CDI other than fidaxomicin Type

Layout table for study information
Study Type : Observational
Actual Enrollment : 296 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients (DAFNE Study)
Actual Study Start Date : September 3, 2014
Actual Primary Completion Date : March 27, 2017
Actual Study Completion Date : August 17, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Fidaxomicin

Group/Cohort Intervention/treatment
1: CDI in patients treated with fidaxomicin
Diagnosed with a CDI and treated with fidaxomicin
Drug: Fidaxomicin
oral
Other Names:
  • Dificid
  • ASP2819
  • Dificlir

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
Oral




Primary Outcome Measures :
  1. Characteristics of patients treated with fidaxomicin, including demographic data, description of comorbidities and treatment by antibiotherapy [ Time Frame: Day 1 ]
  2. 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 [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Therapeutic management of the CDI, including the starting date of the treatment, CDI treatment first line and associated treatment [ Time Frame: Day 1 ]
    For patients treated with fidaxomicin

  2. Number and timing of recurrences in patients treated with fidaxomicin over a 3-month follow-up period [ Time Frame: End of the follow-up (3 months) ]
  3. Adverse events and serious adverse events occurring on fidaxomicin [ Time Frame: End of the follow-up (3 months) ]
  4. Characteristics of patients diagnosed with CDI, including demographic data and treatment by antibiotherapy [ Time Frame: Day 1 ]
    For all patients diagnosed with CDI regardless of treatment

  5. 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 [ Time Frame: Day 1 ]
    For all patients diagnosed with CDI regardless of treatment

  6. Treatment of the CDI including treatment selected and dosage [ Time Frame: Day 1 ]
    For all patients diagnosed with CDI regardless of treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult hospitalized patients diagnosed with clostridium difficile infection
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214771


Locations
Layout table for location information
France
Site
Bethune, France
Site
Bordeaux, France
Site
Boulogne Billancourt, France
Site
Caen Cedex 9, France
Site
Chambéry, France
Site
Clermond-Ferrand, France
Site
Clichy, France
Site
Dijon, France
Site
Garches, France
Site
La Tronche, France
Site
Lille, France
Site
Lyon, France
Site
Marseille, France
Site
Morlaix, France
Site
Mulhouse, France
Site
Nantes, France
Site
Nimes, France
Site
Orléans Cedex 2, France
Site
Paris, France
Site
Poitiers, France
Site
Reims, France
Site
Rennes Cedex, France
Site
Roubaix Cedex 1, France
Site
Soissons, France
Sponsors and Collaborators
Astellas Pharma S.A.S.
Investigators
Layout table for investigator information
Study Director: Medical and Scientific Affairs manager Astellas Pharma S.A.S.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Astellas Pharma S.A.S.
ClinicalTrials.gov Identifier: NCT02214771    
Other Study ID Numbers: FR-FID-NI-001
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Astellas Pharma Inc ( Astellas Pharma S.A.S. ):
Clostridium difficile infection CDI
Observational
Fidaxomicin recurrence
France
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Communicable Diseases
Clostridium Infections
Disease Attributes
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Fidaxomicin
Anti-Bacterial Agents
Anti-Infective Agents