Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-01 @ 1:38 PM
Study NCT ID:
NCT05256693
Status:
UNKNOWN
Last Update Posted:
2022-02-25
First Post:
2022-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of C.Difficile Infections With Oral Vancomycine in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003015', 'term': 'Clostridium Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014640', 'term': 'Vancomycin'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 336}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-17', 'studyFirstSubmitDate': '2022-01-28', 'studyFirstSubmitQcDate': '2022-02-17', 'lastUpdatePostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with Clostridium difficile infection', 'timeFrame': '5 weeks', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with Clostridium difficile infection', 'timeFrame': '12 weeks', 'description': '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).'}, {'measure': 'Cumulative incidence of Clostridium difficile infection', 'timeFrame': '5 weeks', 'description': '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).'}, {'measure': 'Proportion of patients with Clostridium difficile infection by PCR testing', 'timeFrame': '5 weeks', 'description': '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).'}, {'measure': 'Factors associated with the proportion of patients with Clostridium difficile infection', 'timeFrame': '5 weeks', 'description': 'Candidate factors associated with Clostridium difficile infection: antibiotics, toxinogenic strain at baseline, microbiota composition'}, {'measure': 'Proportion of patients with severe Clostridium difficile infection', 'timeFrame': '5 weeks', 'description': 'Severe Clostridium difficile infection defined as at least one of the following: fulminans colitis, toxic megacolon, dehydration, neutrophils blood count\\>20000/mm3, general deterioration'}, {'measure': 'Proportion of patients with bacterial infection', 'timeFrame': '5 weeks', 'description': 'Bacterial infection defined as occurrence of a bacterial infection (any site)'}, {'measure': 'Proportion of patients with vancomycin-resistant enterococcus carriage', 'timeFrame': '5 weeks', 'description': 'Carriage defined as occurrence of vancomycin-resistant enterococcus carriage on rectal swab'}, {'measure': 'Gut microbiome profile', 'timeFrame': '12 weeks', 'description': 'Evolution of gut microbiome profile during the study'}, {'measure': 'Nosocomial Clostridium difficile infection clusters', 'timeFrame': '12 weeks', 'description': 'Defined as at least 2 cases of Clostridium difficile infection in the department within 12 weeks'}, {'measure': 'Proportion of patients with Graft-versus-Host disease', 'timeFrame': '12 months', 'description': 'Graft-versus-Host disease, acute or chronic, grade 2 to 4'}, {'measure': 'Cumulative incidence of relapse', 'timeFrame': '12 months', 'description': 'Time between inclusion and hemopathy relapse or last follow-up, up to a maximum of 12 months'}, {'measure': 'Treatment-related mortality', 'timeFrame': '5 weeks', 'description': 'Proportion of death related to allogeneic stem cell transplant procedures'}, {'measure': 'Overall survival', 'timeFrame': '12 months', 'description': 'Time between inclusion and death or last follow-up, up to a maximum of 12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clostridium Difficile Infections', 'Stem Cell Transplant Complications']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥15 ans\n* Hospitalization since less than 72 hours, for an allogeneic stem cell transplant, whichever the indication and conditioning\n* For men and women of reproductive age: use of contraceptives\n* Informed consent\n* Healthcare insurance\n\nExclusion Criteria:\n\n* Know allergy or history of adverse events with vancomycine\n* Pregnancy\n* Clostridium difficile infection within 30 days prior to inclusion or at inclusion\n* History of total colectomy and/or inflammatory bowel disease\n* Progressive diarrhea at inclusion, whichever the etiology\n* Digestive decontamination protocol for the stem cell transplant procedure\n* Participation to another drug clinical trial or being in the exclusion period from a prior clinical trial participation'}, 'identificationModule': {'nctId': 'NCT05256693', 'acronym': 'VANCALLO', 'briefTitle': 'Prevention of C.Difficile Infections With Oral Vancomycine in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Prevention of C.Difficile Infections With Oral Vancomycine in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant: a Double-blind Placebo-controlled Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'APHP210089'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vancomycine', 'description': '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.', 'interventionNames': ['Drug: Vancomycin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vancomycin', 'type': 'DRUG', 'description': 'Oral vancomycin (powder) 125mg twice a day', 'armGroupLabels': ['Vancomycine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Vancomycine placebo (powder) twice a day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Inès Boussen, MD', 'role': 'CONTACT', 'email': 'ines.boussen@aphp.fr', 'phone': '+33 1 42 49 90 66'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'GIRCI Ile de France', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}