Clinical trial NCT05256693: Prevention of C.Difficile Infections With Oral Vancomycine in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Official title: Prevention of C.Difficile Infections With Oral Vancomycine in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant: a Double-blind Placebo-controlled Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Clostridium Difficile Infections
Stem Cell Transplant Complications
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: GIRCI Ile de France
First posted: 2022-02-25
Enrollment: 336
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Clostridium difficile (CD) infection are an important cause of morbi-mortality in patients undergoing allogeneic hematopoietic stem cell transplant (HSCT). The VANCALLO trial aims at evaluating oral vancomycine reducing the risk of CD infection relying on a placebo controlled 1:1 randomized design, including one interim analysis.


Eligibility criteria: Inclusion Criteria:

* Age ≥15 ans
* 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:

* Know allergy or history of adverse events with vancomycine
* 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

Primary outcomes:
measure: Proportion of patients with Clostridium difficile infection
timeFrame: 5 weeks
Secondary outcomes:
measure: Proportion of patients with Clostridium difficile infection
timeFrame: 12 weeks
measure: Cumulative incidence of Clostridium difficile infection
timeFrame: 5 weeks
measure: Proportion of patients with Clostridium difficile infection by PCR testing
timeFrame: 5 weeks
measure: Factors associated with the proportion of patients with Clostridium difficile infection
timeFrame: 5 weeks
measure: Proportion of patients with severe Clostridium difficile infection
timeFrame: 5 weeks
measure: Proportion of patients with bacterial infection
timeFrame: 5 weeks
measure: Proportion of patients with vancomycin-resistant enterococcus carriage
timeFrame: 5 weeks
measure: Gut microbiome profile
timeFrame: 12 weeks
measure: Nosocomial Clostridium difficile infection clusters
timeFrame: 12 weeks
measure: Proportion of patients with Graft-versus-Host disease
timeFrame: 12 months
measure: Cumulative incidence of relapse
timeFrame: 12 months
measure: Treatment-related mortality
timeFrame: 5 weeks
measure: Overall survival
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
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