Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-24 @ 2:08 PM
Study NCT ID:
NCT04246151
Status:
WITHDRAWN
Last Update Posted:
2025-02-20
First Post:
2020-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Vancomycin Versus Probiotics Versus Placebo for Prevention of Clostridium Difficile Infection in Colonized Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014640', 'term': 'Vancomycin'}, {'id': 'D019936', 'term': 'Probiotics'}], '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'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Blinding will be done in a double-blind fashion. The patients, their caregiver, and the investigator will be blinded to the study treatment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized to receive either a probiotic, oral vancomycin, or placebo in a parallel-group 1:1:1 design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No patients enrolled. Identification of patients in allocated timeframe was not feasible.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2020-01-20', 'studyFirstSubmitQcDate': '2020-01-28', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients identified and randomized to a treatment arm within 72 hour of beginning a systematic antibiotic.', 'timeFrame': '1 year', 'description': 'Feasibility will be assessed using the following parameters:\n\nProportion of eligible participants screened that are randomized within 72 hours of antibiotic exposure (goal ≥ 90%)\n\n* Proportion of participants receiving all doses of study medication (goal ≥ 90%)\n* Proportion of participants with complete follow up at 14 days (goal ≥ 95%)'}, {'measure': 'Development of C difficile associated diarrhea within 14 days of randomization', 'timeFrame': '1 year', 'description': 'Development of C difficile associated diarrhea within 14 days of randomization to one of the treatment arms as defined by the Provincial Infectious Diseases Advisory Committee (PIDAC)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clostridium Difficile Colonization', 'Clostridium Difficile Diarrhea']}, 'descriptionModule': {'briefSummary': 'The goal of this pilot study is to assess the feasibility of randomizing hospitalized patients that are colonized with C. difficile and started on systemic antibiotics to either a probiotic, oral vancomycin, or placebo in a parallel-group 1:1:1 design. The ultimate goal is to conduct an appropriately-powered RCT to determine the optimal method for reducing C difficile infection in colonized patients.', 'detailedDescription': 'In this study, patients will be screened for C. difficile colonization'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients of 18 years of age or older identified as asymptomatic carriers of C. difficile (i.e. not meeting case definition of C. difficile infection, see below)\n* Started on systemic (oral or intravenous) antibiotics for any (presumed) bacterial infection\n* Patient must have vitals (heart rate, blood pressure, temperature), estimated creatinine clearance (using the Chronic Kidney Disease Epidemiology equation (CKD-Epi)) and a complete blood count available within 24 hours of enrolment\n\nExclusion Criteria:\n\n* On a course of systemic antibiotics that had been started more than 72 hours ago (as current evidence suggests that the earlier probiotics are started, the more efficacious they are)\n* Patient with C. difficile, i.e. presence of diarrhea (three or more loose or watery stools within 24 hours), or fevers or hypotension from C. difficile infection\n* Any patients with contra-indications to probiotics or vancomycin:\n\n * Immunosuppressed (primary or acquired immunodeficiency, including AIDS (defined as AIDS defining condition or cluster of differentiation 4 (CD4) nadir of \\<200/ul), hematologic malignancies, long-term systemic corticosteroid treatment, active treatment with chemotherapeutic agents or biologicals, autoimmune diseases, nephrotic syndrome)\n * Structural heart disease (e.g. atrial septal defect, ventricular septal defect)\n * Gastroesophageal or compromised gut integrity (e.g. short gut syndrome, intestinal injury or dysfunction, inflammatory bowel diseases including current or past history of Crohn's disease and ulcerative colitis)\n * Patients on systemic aminoglycosides, ethacrynic acid, polymixin B, or colistin.\n * Prior or current hearing loss\n * Female patients with known pregnancy or who are planning to get pregnant, or who are breastfeeding\n * Patients with end-stage renal diseases defined as an estimated glomerular filtration rate of \\<15ml/min, or absence of a current estimated creatinine clearance\n * History of an allergic reaction to one of the study drugs, or sensitivity to milk\n* Patients started on probiotics or oral vancomycin while in hospital"}, 'identificationModule': {'nctId': 'NCT04246151', 'acronym': 'Decency-RCT', 'briefTitle': 'Oral Vancomycin Versus Probiotics Versus Placebo for Prevention of Clostridium Difficile Infection in Colonized Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hamilton Health Sciences Corporation'}, 'officialTitle': 'Oral Vancomycin Versus Probiotics Versus Placebo for Prevention of Clostridium Difficile Infection in Colonized Patients (Decency-RCT): A Randomized Controlled Pilot Trial', 'orgStudyIdInfo': {'id': 'DECENCY-RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vancomycin & probiotic placebo', 'description': 'Vancomycin 125 mg orally every 12 hours plus probiotic placebo orally every 12 hours for the duration of systematic antibiotic for a maximum of 21 days.', 'interventionNames': ['Drug: Vancomycin', 'Drug: Probiotic Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Probiotic & vancomycin placebo', 'description': 'Culturelle probiotic 20 billion active units orally every 12 hours plus vancomycin placebo orally every 12 hours for the duration of systematic antibiotic for a maximum of 21 days.', 'interventionNames': ['Dietary Supplement: Culturelle', 'Drug: Vancomycin Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Probiotic placebo & vancomycin placebo', 'description': 'Vancomycin placebo orally every 12 hours and Culturelle placebo orally every 12 hours for the duration of systematic antibiotic for a maximum of 21 days.', 'interventionNames': ['Drug: Vancomycin Placebo', 'Drug: Probiotic Placebo']}], 'interventions': [{'name': 'Vancomycin', 'type': 'DRUG', 'otherNames': ['JAMP-vancomycin'], 'description': 'Vancomycin capsules', 'armGroupLabels': ['Vancomycin & probiotic placebo']}, {'name': 'Culturelle', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Lactobacillus rhamnosus GG'], 'description': 'Culturelle capsules', 'armGroupLabels': ['Probiotic & vancomycin placebo']}, {'name': 'Vancomycin Placebo', 'type': 'DRUG', 'otherNames': ['Placebo for Vancomycin'], 'description': 'sugar pill manufactured to mimic the vancomycin 125 mg capsule', 'armGroupLabels': ['Probiotic & vancomycin placebo', 'Probiotic placebo & vancomycin placebo']}, {'name': 'Probiotic Placebo', 'type': 'DRUG', 'otherNames': ['Placebo for probiotic'], 'description': 'sugar pill manufactured to mimic 10 billion unit probiotic capsules.', 'armGroupLabels': ['Probiotic placebo & vancomycin placebo', 'Vancomycin & probiotic placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8N 4A6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Healthcare Hamilton", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8V 1C3', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual participant data will be shared with researchers that are not directly involved in this study. Overall data will be shared in the context of peer reviewed journal publications or scientific presentations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}