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Completed

NCT Number: NCT02214771

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

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).

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Key information

Conditions

Clostridium Difficile Infection Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fidaxomicin

Drug

oral

Other names: Dificid, ASP2819, Dificlir

Treatment for CDI other than fidaxomicin Type

Drug

Oral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Astellas Pharma S.A.S.

Industry

Registry information

Official study title

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

Acronym: DAFNE

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 12, 2014
Registry last updated
Oct 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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