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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
336
Oral vancomycin (powder) 125mg twice a day
Vancomycine placebo (powder) twice a day
Proportion of patients with Clostridium difficile infection
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).
Time frame: 5 weeks
Proportion of patients with Clostridium difficile infection
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).
Time frame: 12 weeks
Cumulative incidence of Clostridium difficile infection
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).
Time frame: 5 weeks
Proportion of patients with Clostridium difficile infection by PCR testing
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).
Time frame: 5 weeks
Factors associated with the proportion of patients with Clostridium difficile infection
Candidate factors associated with Clostridium difficile infection: antibiotics, toxinogenic strain at baseline, microbiota composition
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Time frame: 5 weeks
Proportion of patients with severe Clostridium difficile infection
Severe Clostridium difficile infection defined as at least one of the following: fulminans colitis, toxic megacolon, dehydration, neutrophils blood count\>20000/mm3, general deterioration
Time frame: 5 weeks
Proportion of patients with bacterial infection
Bacterial infection defined as occurrence of a bacterial infection (any site)
Time frame: 5 weeks
Proportion of patients with vancomycin-resistant enterococcus carriage
Carriage defined as occurrence of vancomycin-resistant enterococcus carriage on rectal swab
Time frame: 5 weeks
Gut microbiome profile
Evolution of gut microbiome profile during the study
Time frame: 12 weeks
Nosocomial Clostridium difficile infection clusters
Defined as at least 2 cases of Clostridium difficile infection in the department within 12 weeks
Time frame: 12 weeks
Proportion of patients with Graft-versus-Host disease
Graft-versus-Host disease, acute or chronic, grade 2 to 4
Time frame: 12 months
Cumulative incidence of relapse
Time between inclusion and hemopathy relapse or last follow-up, up to a maximum of 12 months
Time frame: 12 months
Treatment-related mortality
Proportion of death related to allogeneic stem cell transplant procedures
Time frame: 5 weeks
Overall survival
Time between inclusion and death or last follow-up, up to a maximum of 12 months
Time frame: 12 months