Clostridium Difficile Infections, Stem Cell Transplant Complications
Conditions
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.
Interventions
DRUGVancomycin
Oral vancomycin (powder) 125mg twice a day
DRUGPlacebo
Vancomycine placebo (powder) twice a day
Sponsors
GIRCI Ile de France
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with Clostridium difficile infection | 5 weeks | Clostridium difficile infection defined as a diarrhea (\> 3 loose stools/day) with positive Clostridium difficile testing and free-toxin in stools by enzyme-linked immunosorbent assay (ELISA), without other obvious etiology for diarrhea nor pseudo-membraneous colitis (endoscopy, colectomy, autopsy). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of Clostridium difficile infection | 5 weeks | Time between inclusion and Clostridium difficile infection, occurring before hospital discharge or the end of study treatment (that is 5 weeks from inclusion if the patient is still hospitalized), defined as a diarrhea (\> 3 loose stools/day) with positive Clostridium difficile testing and free-toxin in stools by enzyme-linked immunosorbent assay (ELISA), without other obvious etiology for diarrhea nor pseudo-membraneous colitis (endoscopy, colectomy, autopsy). |
| Proportion of patients with Clostridium difficile infection by PCR testing | 5 weeks | Clostridium difficile infection defined as a diarrhea (\> 3 loose stools/day) with positive toxinogenic Clostridium difficile PCR (polymerase chain reaction) testing, without other obvious etiology for diarrhea nor pseudo-membraneous colitis (endoscopy, colectomy, autopsy). |
| Factors associated with the proportion of patients with Clostridium difficile infection | 5 weeks | Candidate factors associated with Clostridium difficile infection: antibiotics, toxinogenic strain at baseline, microbiota composition |
| Proportion of patients with severe Clostridium difficile infection | 5 weeks | Severe Clostridium difficile infection defined as at least one of the following: fulminans colitis, toxic megacolon, dehydration, neutrophils blood count\>20000/mm3, general deterioration |
| Proportion of patients with bacterial infection | 5 weeks | Bacterial infection defined as occurrence of a bacterial infection (any site) |
| Proportion of patients with vancomycin-resistant enterococcus carriage | 5 weeks | Carriage defined as occurrence of vancomycin-resistant enterococcus carriage on rectal swab |
| Proportion of patients with Clostridium difficile infection | 12 weeks | Clostridium difficile infection defined as a diarrhea (\> 3 loose stools/day) with positive Clostridium difficile testing and free-toxin in stools by enzyme-linked immunosorbent assay (ELISA), without other obvious etiology for diarrhea nor pseudo-membraneous colitis (endoscopy, colectomy, autopsy). |
| Nosocomial Clostridium difficile infection clusters | 12 weeks | Defined as at least 2 cases of Clostridium difficile infection in the department within 12 weeks |
| Proportion of patients with Graft-versus-Host disease | 12 months | Graft-versus-Host disease, acute or chronic, grade 2 to 4 |
| Cumulative incidence of relapse | 12 months | Time between inclusion and hemopathy relapse or last follow-up, up to a maximum of 12 months |
| Treatment-related mortality | 5 weeks | Proportion of death related to allogeneic stem cell transplant procedures |
| Overall survival | 12 months | Time between inclusion and death or last follow-up, up to a maximum of 12 months |
| Gut microbiome profile | 12 weeks | Evolution of gut microbiome profile during the study |
Contacts
Primary ContactInès Boussen, MD
Outcome results
None listed