Prevention of C.Difficile Infections With Oral Vancomycine in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
NCT ID: NCT05256693
Last Updated: 2022-02-25
Study Results
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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UNKNOWN
PHASE3
336 participants
INTERVENTIONAL
2022-03-31
2025-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Vancomycine
Oral vancomycine 125 mg twice a day, from inclusion (at the time of hospitalization for allogeneic stem cell transplant) until hospital discharge or 5 weeks in hospital at most.
Vancomycin
Oral vancomycin (powder) 125mg twice a day
Placebo
Vancomycine placebo, twice a day, from inclusion (at the time of hospitalization for allogeneic stem cell transplant) until hospital discharge or 5 weeks in hospital at most.
Placebo
Vancomycine placebo (powder) twice a day
Interventions
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Vancomycin
Oral vancomycin (powder) 125mg twice a day
Placebo
Vancomycine placebo (powder) twice a day
Eligibility Criteria
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Inclusion Criteria
* Hospitalization since less than 72 hours, for an allogeneic stem cell transplant, whichever the indication and conditioning
* For men and women of reproductive age: use of contraceptives
* Informed consent
* Healthcare insurance
Exclusion Criteria
* Pregnancy
* Clostridium difficile infection within 30 days prior to inclusion or at inclusion
* History of total colectomy and/or inflammatory bowel disease
* Progressive diarrhea at inclusion, whichever the etiology
* Digestive decontamination protocol for the stem cell transplant procedure
* Participation to another drug clinical trial or being in the exclusion period from a prior clinical trial participation
15 Years
ALL
No
Sponsors
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GIRCI Ile de France
UNKNOWN
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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APHP210089
Identifier Type: -
Identifier Source: org_study_id
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