VANCOMYCIN for Clostridium difficile infection | Hematopoietic stem cell transplantation (allogeneic)

Inclusion criteria

• {"criterion_text":"- Age ≥15 years\n- Patient hospitalized for less than 72 hours to receive an allograft of HSC, whatever the indication and packaging,\n- 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)\n- Have given consent for participation in the study.\n- Beneficiary of health insurance"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Diarrhea >3 unformed stools/day plus detection of C. difficile (GDH) and free toxin in stools by enzyme immunoassay; alternative diagnostic evidence includes pseudomembranous colitis at endoscopy, colectomy or autopsy. Window: between inclusion and discharge or end of treatment (up to W5 if still hospitalized)."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Diarrhea >3 unformed stools/day plus detection of C. difficile and free toxin in stools by immunoenzymatic method or pseudomembranous colitis on endoscopy/colectomy/autopsy. Window: inclusion to W12."}
• {"endpoint_text":"- Time between inclusion and Clostridium difficile infection as defined in the primary endpoint, in a maximum window up to W5","definition_or_measurement_approach":"Time-to-event (days) from inclusion to CDI as per primary endpoint definition, censored at W5 maximum."}
• {"endpoint_text":"- 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 a diarrhoea (> 3 unformed stools/day) with detection of toxigenic CD by PCR without argument for another etiology of diarrhoea or existence of pseudomembranous colitis at endoscopy, colectomy or autopsy.","definition_or_measurement_approach":"Diarrhea >3 unformed stools/day plus detection of toxigenic C. difficile by PCR; alternative evidence as above. Window: inclusion to discharge or end of treatment (up to W5 if still hospitalized)."}
• {"endpoint_text":"- Risk factors for CD infection: type of packaging, antibiotics received, presence of toxigenic strain on D0 of treatment (D0V), composition of the microbiota","definition_or_measurement_approach":"Assessment of associations between CDI occurrence and variables including conditioning type, antibiotics administered, presence of toxigenic strain at D0V, and microbiota composition (ancillary study)."}
• {"endpoint_text":"- Severity factors of CD infections occurring during the procedure","definition_or_measurement_approach":"Evaluation of severity metrics for CDI episodes occurring during the study period (method not further specified)."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Microbiologically documented bacterial infections during treatment period with 125 mg vancomycin (up to 5 weeks); documentation via standard microbiology results."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Rectal swab surveillance for VRE carriage between randomization and end of treatment (discharge or W5)."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Microbiota composition analysis at baseline, W2, W5 (or before discharge) and W12 as part of ancillary study (methods not further specified)."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Identification of nosocomial clusters defined as >=2 CDI cases within a center-specific time period by W12."}
• {"endpoint_text":"- Occurrence of acute or chronic GVHD grade 2-4 at M12","definition_or_measurement_approach":"Assessment of acute or chronic graft-versus-host disease grade 2-4 occurrence at month 12 (M12) using standard clinical grading."}
• {"endpoint_text":"- Time between inclusion and relapse of the hematological disease, or the date of last news (maximum M12)","definition_or_measurement_approach":"Time-to-relapse or censoring at date of last contact, up to M12."}
• {"endpoint_text":"- Mortality rate linked to the transplant procedure (TRM) at W5","definition_or_measurement_approach":"Transplant-related mortality rate assessed at W5."}
• {"endpoint_text":"- Delay between inclusion and death, or the date of last news (maximum M12)","definition_or_measurement_approach":"Time from inclusion to death or last contact, censored at M12."}
• {"endpoint_text":"- Proportion of adverse effects during protocol monitoring","definition_or_measurement_approach":"Proportion of participants experiencing adverse events during protocol follow-up (safety monitoring)."}

France

Earliest CTIS Part Ii Submission Date

18-06-2024

Latest Decision Or Authorization Date

26-06-2024

Processing Time Days

8

Number Of Sites

7

Number Of Participants

336

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France