Prevention of C.Difficile Infections With Oral Vancomycine in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (VANCALLO)

Assistance Publique - Hôpitaux de Paris

Status and phase: Not yet enrolling; Phase 3

Conditions: Clostridium Difficile Infections; Stem Cell Transplant Complications

Treatments: Drug: Vancomycin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05256693

APHP210089

Details and patient eligibility

About

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.

Enrollment: 336 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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336 participants in 2 patient groups, including a placebo group

Vancomycine

Experimental group

Description:

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.

Treatment:

Drug: Vancomycin

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo