VANCALLO - Prevention of C. difficile infections by oral vancomycin in patients treated for allogeneic hematopoietic stem cell transplantation, a randomized double-blind placebo-controlled trial

Phase 3

Recruiting

Conditions: Patients hospitalized for allogeneic hematopoietic stem cell transplantation

Registration Number: 2024-513490-45-00

Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary: Evaluate the effectiveness of primary prophylaxis with oral vancomycin on the prevention of Clostridium difficile infections in patients hospitalized for allogeneic HCT transplantation.

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

Target Recruitment: 336

Inclusion Criteria

Age ≥15 years
Patient hospitalized for less than 72 hours to receive an allograft of HSC, whatever the indication and packaging,
for men and women of childbearing age: use of effective contraception (failure rate less than 1% per year) throughout the Research and up to 1 month after the end of treatment (see point 6.1 Inclusion criteria)
Have given consent for participation in the study.
Beneficiary of health insurance

Exclusion Criteria

Documented allergy or adverse reactions to vancomycin
Pregnancy and breast feeding
Clostridium difficile infection within 30 days preceding inclusion or on the day of inclusion
History of total colectomy and/or chronic inflammatory bowel disease
Progressive diarrhea at inclusion regardless of the etiology
Digestive decontamination protocol during the transplant procedure
Participation in another medicinal intervention research involving humans or being in the exclusion period following previous research involving humans, if applicable

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clostridium difficile infection, occurring between inclusion and discharge from hospitalization or the end of treatment with vancomycin or placebo (i.e. after 5 weeks of treatment (W5) if the patient is still hospitalized), defined by diarrhea (> 3 unformed stools/day) with detection of CD (GDH) and free toxin in the stools by enzyme immunoassay without argument for another etiology of diarrhea or existence of pseudomembranous colitis at endoscopy, at colectomy or at autopsy.		Clostridium difficile infection, occurring between inclusion and discharge from hospitalization or the end of treatment with vancomycin or placebo (i.e. after 5 weeks of treatment (W5) if the patient is still hospitalized), defined by diarrhea (> 3 unformed stools/day) with detection of CD (GDH) and free toxin in the stools by enzyme immunoassay without argument for another etiology of diarrhea or existence of pseudomembranous colitis at endoscopy, at colectomy or at autopsy.

Secondary Outcome Measures

Name	Time	Method
- Risk factors for CD infection: type of packaging, antibiotics received, presence of toxigenic strain on D0 of treatment (D0V), composition of the microbiota		- Risk factors for CD infection: type of packaging, antibiotics received, presence of toxigenic strain on D0 of treatment (D0V), composition of the microbiota
- Severity factors of CD infections occurring during the procedure		- Severity factors of CD infections occurring during the procedure
- Clostridium difficile infection, occurring between inclusion and W12, defined by diarrhea (> 3 unformed stools/day) with detection of CD and free toxin in the stools by immunoenzymatic method without argument for another etiology in diarrhea or presence of pseudomembranous colitis at endoscopy, colectomy or autopsy.		- Clostridium difficile infection, occurring between inclusion and W12, defined by diarrhea (> 3 unformed stools/day) with detection of CD and free toxin in the stools by immunoenzymatic method without argument for another etiology in diarrhea or presence of pseudomembranous colitis at endoscopy, colectomy or autopsy.
- Time between inclusion and Clostridium difficile infection as defined in the primary endpoint, in a maximum window up to W5		- Time between inclusion and Clostridium difficile infection as defined in the primary endpoint, in a maximum window up to W5
- Clostridium difficile infection, occurring between inclusion and discharge from hospitalization or the end of treatment with vancomycin or placebo (i.e. after 5 weeks of treatment (W5) if the patient is still hospitalized), defined by diarrhea (> 3 unformed stools/day) with detection of toxigenic CD by PCR without argument for another etiology of diarrhea or existence of pseudomembranous colitis at endoscopy, colectomy or autopsy.		- Clostridium difficile infection, occurring between inclusion and discharge from hospitalization or the end of treatment with vancomycin or placebo (i.e. after 5 weeks of treatment (W5) if the patient is still hospitalized), defined by diarrhea (> 3 unformed stools/day) with detection of toxigenic CD by PCR without argument for another etiology of diarrhea or existence of pseudomembranous colitis at endoscopy, colectomy or autopsy.
- Microbiologically documented bacterial infection(s) (regardless of the infectious source) occurring during treatment with 125 mg of vancomycin (i.e. up to 5 weeks maximum)		- Microbiologically documented bacterial infection(s) (regardless of the infectious source) occurring during treatment with 125 mg of vancomycin (i.e. up to 5 weeks maximum)
- Acquisition of rectal carriage of vancomycin-resistant Enterococcus (VRE) between randomization and the end of treatment (discharge from hospitalization or W5 maximum) measured by rectal swab		- Acquisition of rectal carriage of vancomycin-resistant Enterococcus (VRE) between randomization and the end of treatment (discharge from hospitalization or W5 maximum) measured by rectal swab
- Study of the intestinal microbiota at inclusion, during treatment (14 days after initiation of treatment, i.e. W2), at the end of treatment (W5 or before discharge from hospitalization) and remotely (W12) as part of the ancillary study		- Study of the intestinal microbiota at inclusion, during treatment (14 days after initiation of treatment, i.e. W2), at the end of treatment (W5 or before discharge from hospitalization) and remotely (W12) as part of the ancillary study
- Occurrence of nosocomial clusters of CD infection at W12 defined as the occurrence of at least 2 cases of CDI over a period of time defined according to the incidence usually observed in the investigating center		- Occurrence of nosocomial clusters of CD infection at W12 defined as the occurrence of at least 2 cases of CDI over a period of time defined according to the incidence usually observed in the investigating center
- Occurrence of acute or chronic GVHD grade 2-4 at M12		- Occurrence of acute or chronic GVHD grade 2-4 at M12
- Time between inclusion and relapse of the hematological disease, or the date of last news (maximum M12)		- Time between inclusion and relapse of the hematological disease, or the date of last news (maximum M12)
- Mortality rate linked to the transplant procedure (TRM) at W5		- Mortality rate linked to the transplant procedure (TRM) at W5
- Delay between inclusion and death, or the date of last news (maximum M12)		- Delay between inclusion and death, or the date of last news (maximum M12)
- Proportion of adverse effects during protocol monitoring		- Proportion of adverse effects during protocol monitoring

Trial Locations

Locations (6): Centre Hospitalier Universitaire De Nantes
🇫🇷
Nantes, France
Assistance Publique Hopitaux De Paris
🇫🇷
Paris, France
Centre Hospitalier Regional Universitaire De Tours
🇫🇷
Tours Cedex 9, France
Hopital D'Instruction Des Armees Percy
🇫🇷
Clamart, France
Centre Hospitalier Universitaire De Rennes
🇫🇷
Rennes, France
Centre Hospitalier Universitaire Grenoble Alpes
🇫🇷
Grenoble Cedex 9, France
Centre Hospitalier Universitaire De Nantes
🇫🇷Nantes, France
patrice CHEVALLIER
Site contact
0240083271
patrice.chevallier@chu-nantes.fr