Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GIRCI Ile de France | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vancomycine | Experimental | Oral vancomycine 125 mg twice a day, from inclusion (at the time of hospitalization for allogeneic stem cell transplant) until hospital discharge or 5 weeks in hospital at most. |
|
| Placebo | Placebo Comparator | Vancomycine placebo, twice a day, from inclusion (at the time of hospitalization for allogeneic stem cell transplant) until hospital discharge or 5 weeks in hospital at most. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin | Drug | Oral vancomycin (powder) 125mg twice a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Inès Boussen, MD | Contact | +33 1 42 49 90 66 | ines.boussen@aphp.fr |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Vancomycine placebo (powder) twice a day |
|
| 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). | 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). | 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 | 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 | 5 weeks |
| Proportion of patients with bacterial infection | Bacterial infection defined as occurrence of a bacterial infection (any site) | 5 weeks |
| Proportion of patients with vancomycin-resistant enterococcus carriage | Carriage defined as occurrence of vancomycin-resistant enterococcus carriage on rectal swab | 5 weeks |
| Gut microbiome profile | Evolution of gut microbiome profile during the study | 12 weeks |
| Nosocomial Clostridium difficile infection clusters | Defined as at least 2 cases of Clostridium difficile infection in the department within 12 weeks | 12 weeks |
| Proportion of patients with Graft-versus-Host disease | Graft-versus-Host disease, acute or chronic, grade 2 to 4 | 12 months |
| Cumulative incidence of relapse | Time between inclusion and hemopathy relapse or last follow-up, up to a maximum of 12 months | 12 months |
| Treatment-related mortality | Proportion of death related to allogeneic stem cell transplant procedures | 5 weeks |
| Overall survival | Time between inclusion and death or last follow-up, up to a maximum of 12 months | 12 months |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided