Patients hospitalized for an allogeneic hematopoietic stem cell transplant MedDRA version: 22.0 Level: LLT Classification code 10059044 Term: Allogeneic peripheral hematopoietic stem cell transplant System Organ Class: 100000004865
Conditions
Interventions
Product Name: VANCOMYCIN
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: VANCOMYCIN
CAS Number: 1404-90-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age =15 years - Patient hospitalized for less than 72 hours to receive an allogeneic CSH transplant, regardless of the indication and the packaging, - for men and women of childbearing age: use of effective contraception - Have given their consent to participate in the study. - Beneficiary of health insurance Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 270 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 33
Exclusion criteria
Exclusion criteria: - Documented allergy or side effects to vancomycin - Pregnancy and breast feeding - Clostridium difficile infection within 30 days prior to inclusion or on the day of inclusion - History of total colectomy and / or chronic inflammatory bowel disease - Active diarrhea on inclusion regardless of the aetiology - Digestive decontamination protocol during the transplant procedure - Participation in another drug intervention research involving the human person or being in the exclusion period following a previous research involving the human person, if applicable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of oral vancomycin prophylaxis in preventing Clostridium difficile infections in patients hospitalized for allogeneic HSC transplantation. ;Secondary Objective: In HSCT patients, assess the impact of oral vancomycin prophylaxis on: - Prevention of CD infections occurring after stopping prophylaxis (qsp S12) - Prevention of CD infections in hospitalized patients for HSCT (qsp S5) - Prevention of CD infections in hospitalized patients with a diagnosis made by PCR detection of the toxigenic strain - Severity of CD infections occurring during treatment - Risk factors for CD infection: antibiotics received, presence of toxigenic strain on D0 of treatment, composition of the microbiota - Profile of bacterial infections occurring during treatment with vancomycin - Impact of the treatment on the intestinal microbiota - Emergence of enterococcus resistant to vancomycin - Occurrence of nosocomial clusters of CD infection up to W12 - Onset of acute or chronic GVHD - Relapse of hematological disease - MRT linked to the transplant procedure at 1 month - Overall survival at M12 ;Primary end point(s): Clostridium difficile infection, occurring between inclusion and discharge from hospital or the end of treatment with vancomycin (i.e. after 5 weeks of treatment (W5) if the patient is still hospitalized), defined by diarrhea (> 3 stools not formed / day) with detection of CD (GDH) and free toxin in the stool by enzyme-linked immunosorbent assay without evidence for another etiology to diarrhea or existence of pseudomembranous colitis at endoscopy, colectomy or autopsy;Timepoint(s) of evaluation of this end point: D0 and W5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Clostridium difficile infection, occurring between inclusion and W12, defined by diarrhea (> 3 unformed stools / day) with detection of CD and free toxin in the stool by enzyme-linked immunosorbent assay without evidence for another etiology. diarrhea or existence of pseudomembranous colitis on endoscopy, colectomy or autopsy. - Time between inclusion and Clostridium difficile infection, occurring between inclusion and discharge from hospital or the end of treatment with vancomycin (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 stool by enzyme immunoassay without argument for another etiology to diarrhea or existence of pseudomembranous colitis with endoscopy, colectomy or autopsy or delay in hospital follow-up (for patients discharged or died without infection), at most at W5 - Clostridium difficile infection, occurring between inclusion and discharge from hospital or the end of treatment with vancomycin (i.e. after 5 weeks of treatment (W5) if the patient is still hospitalized), defined by diarrhea (> 3 stools not formed / day) with detection of toxinogenic CD by PCR without argument for another etiology to diarrhea or existence of pseudomembranous colitis at endoscopy, colectomy or autopsy. - Risk factors for CD infection: antibiotics received, presence of toxigenic strain on D0 of treatment (D0V), composition of the microbiota - Severity factors for CD infections occurring during the procedure - Documented bacterial infection (s) (regardless of the infectious focus) occurring during treatment with vancomycin (up to a maximum of 5 weeks) - Acquisition of rectal carriage of Vancomycin-resistant Enterococcus (VRE) between randomization and the end of treatment (discharge from hospital or maximum S5) measured by rectal swabbing - Study of the intestinal microbiota at inclusion, during treatment (14 days after initia | — |
Countries
France
Contacts
Public ContactLEMADRE
ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS
Outcome results
None listed