Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-30 @ 12:39 PM
Study NCT ID:
NCT05389904
Status:
RECRUITING
Last Update Posted:
2025-08-05
First Post:
2022-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-emptive Prevention for Patients at High Risk for Hospital-onset Clostridioides Difficile
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003428', 'term': 'Cross Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2022-05-20', 'studyFirstSubmitQcDate': '2022-05-20', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Oncology and ICU C. difficile infection rates', 'timeFrame': '24 months', 'description': 'Oncology and ICU C. difficile infection incidences before and after implementation of the intervention'}], 'primaryOutcomes': [{'measure': 'Risk of C. difficile infection among patients colonized with C. difficile comparing the intervention to the control group', 'timeFrame': '24 months', 'description': 'Incidence rate ratio of CDI in colonized patients who received the intervention bundle versus who did not receive the intervention bundle'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prevention', 'Hospital-acquired infection'], 'conditions': ['C. Difficile']}, 'descriptionModule': {'briefSummary': 'Clostridioides difficile (C. difficile) is the most common healthcare-associated pathogen, causing \\>500,000 infections and \\>29,000 deaths per year in the US. Traditional approaches to reduce hospital-onset CDI focus on identifying, isolating, and treating symptomatic patients to prevent transmission to other patients. Recent genomic epidemiology studies, however, suggest that most hospital-onset CDI cases are attributable to asymptomatic carriers who either progress from colonization to active infection themselves or transmit C. difficile to other patients while asymptomatic. This trial will evaluate an intervention to pre-emptively identify asymptomatic C. difficile carriers and then implement a patient-tailored prevention package to protect the carrier from progression to active infection and to prevent transmission from the carrier to other patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to ICU or Oncology units and identified to carry C. Difficile via VRE swab\n\nExclusion Criteria:\n\n* Patients not identified as carriers of C. difficile and patients not admitted to ICU or oncology units'}, 'identificationModule': {'nctId': 'NCT05389904', 'briefTitle': 'Pre-emptive Prevention for Patients at High Risk for Hospital-onset Clostridioides Difficile', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'A Pre-emptive Prevention Bundle for Patients at High Risk for Hospital-onset Clostridioides Difficile', 'orgStudyIdInfo': {'id': '2022P000819'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients colonized with toxigenic C. difficile who do not receive the prevention bundle', 'description': 'Patients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, who receive standard of care', 'interventionNames': ['Other: Arm 1: Routine care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients colonized with toxigenic C. difficile who receive the prevention bundle', 'description': 'Patients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, who receive a preemptive prevention bundle for C. difficile including enhanced room cleaning, C. difficile precautions, pharmacist review and optimization of antibiotics and antacids, and consideration of vancomycin prophylaxis.', 'interventionNames': ['Other: Arm 2: Preemptive C. difficile infection prevention bundle']}], 'interventions': [{'name': 'Arm 1: Routine care', 'type': 'OTHER', 'description': 'Patients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, will receive standard of care.', 'armGroupLabels': ['Patients colonized with toxigenic C. difficile who do not receive the prevention bundle']}, {'name': 'Arm 2: Preemptive C. difficile infection prevention bundle', 'type': 'OTHER', 'description': 'Patients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, will receive a preemptive prevention bundle for C. difficile. The prevention bundle will include enhanced room cleaning, C. difficile precautions (staff entering room must wear gown and gloves and wash hands with soap and water upon exiting the room), pharmacist review and optimization of antibiotics and antacids, and consideration of vancomycin prophylaxis.', 'armGroupLabels': ['Patients colonized with toxigenic C. difficile who receive the prevention bundle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Meghan A Baker, MD, SCD', 'role': 'CONTACT'}], 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Meghan A Baker, MD, SCD', 'role': 'CONTACT', 'email': 'mbaker1@bwh.harvard.edu', 'phone': '617-732-8881'}, {'name': 'Sanjat Kanjilal, MD, MPH', 'role': 'CONTACT', 'email': 'skanjilal@bwh.harvar.edu'}], 'overallOfficials': [{'name': 'Meghan A Baker, MD, SCD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Harvard Pilgrim Health Care Institute', 'class': 'UNKNOWN'}, {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, {'name': 'Massachusetts Host-Microbiome Center', 'class': 'UNKNOWN'}, {'name': 'Hatch Family Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Hospital Epidemiologist', 'investigatorFullName': 'Meghan A. Baker, M.D', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}