Clostridium Difficile InfectionDAFNENCT02214771
Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients
An observational study of Clostridium Difficile Infection, run by Astellas Pharma S.A.S. at 24 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- Fidaxomicin and Treatment for CDI other than fidaxomicin Type
- Type of treatment
- Pill or oral medicine
- How many people
- 296 participants
- Where
- 24 sitesFrance
- Study dates
- 3 Sep 2014to 17 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult hospitalized patients diagnosed with clostridium difficile infection
Who may be able to join
- Hospitalized patient
- Patient diagnosed with CDI
Who cannot join
- Patient already included in this study
- Patient is taking part in a clinical trial in the field of CDI
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
France24 sites
Site
Béthune
Site
Bordeaux
Site
Boulogne-Billancourt
Site
Caen
Site
Chambéry
Site
Clermond-Ferrand
Site
Clichy
Site
Dijon
Site
Garches
Site
La Tronche
Site
Lille
Site
Lyon
Site
Marseille
Site
Morlaix
Site
Mulhouse
Site
Nantes
Site
Nîmes
Site
Orléans
Site
Paris
Site
Poitiers
Site
Reims
Site
Rennes
Site
Roubaix
Site
Soissons
About this study
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)
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).
- Conditions
- Clostridium Difficile Infection
- Being tested
- Fidaxomicin, Treatment for CDI other than fidaxomicin Type
- Keywords
- Clostridium difficile infection CDI, Observational, Fidaxomicin recurrence, France
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FidaxomicinDrug
Also called Dificid, ASP2819, Dificlir
oral
Treatment for CDI other than fidaxomicin TypeDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1: CDI in patients treated with fidaxomicin | Diagnosed with a CDI and treated with fidaxomicin Receives: Drug: Fidaxomicin | |
| 2: CDI in patients receiving treatment other than fidaxomicin | Diagnosed with a CDI, regardless of the prescribed treatment (not fidaxomicin) Receives: Drug: Treatment for CDI other than fidaxomicin Type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of patients treated with fidaxomicin, including demographic data, description of comorbidities and treatment by antibiotherapy
Measured: 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
Measured: Day 1
Secondary outcomes (6)
Therapeutic management of the CDI, including the starting date of the treatment, CDI treatment first line and associated treatment
For patients treated with fidaxomicin
Measured: Day 1
Number and timing of recurrences in patients treated with fidaxomicin over a 3-month follow-up period
Measured: End of the follow-up (3 months)
Adverse events and serious adverse events occurring on fidaxomicin
Measured: 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
Measured: 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
Measured: Day 1
Treatment of the CDI including treatment selected and dosage
For all patients diagnosed with CDI regardless of treatment
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study start3 Sep 2014
- Primary completion27 Mar 2017
- Study completion17 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma S.A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical and Scientific Affairs manager, Study director, Astellas Pharma S.A.S.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214771
- Sponsor's protocol ID
- FR-FID-NI-001
- Acronym
- DAFNE
- Status last verified
- Oct 2017
- First submitted
- 13 May 2014
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34162264
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02214771
- Acronym / sponsor ID
- DAFNE / FR-FID-NI-001
- Conditions
- Clostridium Difficile Infection
- Keywords
- Clostridium difficile infection CDI, Observational, Fidaxomicin recurrence, France
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Astellas Pharma S.A.S.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2014 (actual)
- Primary completion
- 27 Mar 2017 (actual)
- Study completion
- 17 Aug 2017 (actual)
- First posted
- 12 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: CDI in patients treated with fidaxomicin | – | Drug: FidaxomicinDiagnosed with a CDI and treated with fidaxomicin |
| 2: CDI in patients receiving treatment other than fidaxomicin | – | Drug: Treatment for CDI other than fidaxomicin TypeDiagnosed with a CDI, regardless of the prescribed treatment (not fidaxomicin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult hospitalized patients diagnosed with clostridium difficile infection
Key inclusion criteria (2 listed)
- Hospitalized patient
- Patient diagnosed with CDI
Key exclusion criteria (2 listed)
- Patient already included in this study
- Patient is taking part in a clinical trial in the field of CDI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FidaxomicinAlso: Dificid, ASP2819, Dificliroral | Drug | 1: CDI in patients treated with fidaxomicin |
| Treatment for CDI other than fidaxomicin TypeOral | Drug | 2: CDI in patients receiving treatment other than fidaxomicin |
Primary outcome
Characteristics of patients treated with fidaxomicin, including demographic data, description of comorbidities and treatment by antibiotherapy
Time frame: 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
Time frame: Day 1
6 secondary outcomes
Therapeutic management of the CDI, including the starting date of the treatment, CDI treatment first line and associated treatment
Time frame: Day 1
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)
Adverse events and serious adverse events occurring on fidaxomicin
Time frame: End of the follow-up (3 months)
Characteristics of patients diagnosed with CDI, including demographic data and treatment by antibiotherapy
Time frame: 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
Time frame: Day 1
Treatment of the CDI including treatment selected and dosage
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Derived from this study: PubMed 34162264Guery 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.
- Individual participant dataSharing planned: Undecided
Related trials for Clostridium Difficile Infection
Not yet recruitingObservational study
Epidemiology of Clostridioides Difficile Infection (CDI) in Long-term Care Facilities, Assessment of Professional Practices Related to CDI Risk Prevention, and Strategies for Improving Care.
Clostridioides Difficile Infection
Active, not recruitingPhase 2
Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell
Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
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Clostridioides Difficile Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical and Scientific Affairs manager study director
Astellas Pharma S.A.S.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Difficile Infection, run by Astellas Pharma S.A.S. at 24 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics of patients treated with fidaxomicin, including demographic data, description of comorbidities and treatment by antibiotherapy (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02214771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2017.