Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT03466502
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2018-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Vancomycin to Prevent Recurrent C Difficile Infection With Antibiotics
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2018-03-08', 'studyFirstSubmitQcDate': '2018-03-14', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent Clostridium difficile infection', 'timeFrame': 'During hospitalization or the 12 weeks after therapy', 'description': 'Diarrheal illness, with at least 3 episodes of watery diarrhea over a 24 hour period and a positive toxin analysis or a positive PCR for Cdiff'}], 'secondaryOutcomes': [{'measure': 'Recurrence rate of CDI according to C diff inducing properties of the prescribed antibiotics', 'timeFrame': 'During hospitalization or the 12 weeks after therapy', 'description': '* Low inducers: aminoglycosides, fosfomycin, glycopeptides, daptomycin, nitrofurantoin, linezolid, polymyxins, rifamycins, antifolates and/or sulfonamides, tetracyclines, tigecycline\n* Moderate inducers: penicillins, 1st generation cephalosporins, macrolides, azithromycin, streptogramins\n* High inducers: carbapenems, 2nd and greater generation cephalosporins, fluoroquinolones, clindamycin'}, {'measure': 'Time between recurrent CDI and the last C diff infection', 'timeFrame': 'During hospitalization or the 12 weeks after therapy'}, {'measure': 'Rate of recurrence of CDI in immunocompromised patients', 'timeFrame': 'During hospitalization or the 12 weeks after therapy', 'description': 'HIV, Organ Transplantation, Current Immunosuppressive therapy, Hypogammaglobulinemia or steroids dose more than prednisone 20mg/day for 3 weeks'}, {'measure': 'Rate of recurrence of CDI in patients with a history of the NAP-1 strain', 'timeFrame': 'During hospitalization or the 12 weeks after therapy'}, {'measure': 'Rate of reported adverse events', 'timeFrame': 'During hospitalization or the 12 weeks after therapy'}, {'measure': 'Mortality rate', 'timeFrame': 'During hospitalization or the 12 weeks after therapy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vancomycin', 'Clostridium difficile', 'Clostridium difficile infection', 'Recurrent Clostridium difficile infection'], 'conditions': ['Clostridium Difficile Infection']}, 'descriptionModule': {'briefSummary': 'This study will assess the efficacy of oral vancomycin prophylaxis in preventing recurrent Clostridium difficile infection in hospitalized patients requiring oral or intravenous antibiotics for a suspected or confirmed bacterial infection.', 'detailedDescription': 'This study will assess the efficacy of oral vancomycin prophylaxis in preventing recurrent Clostridium difficile infection in hospitalized patients requiring oral or intravenous antibiotics for a suspected or confirmed bacterial infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥18 years\n2. Previous CDI diagnosis\n3. Current admission with a suspected or a confirmed bacterial infection requiring antibiotics\n\nExclusion Criteria:\n\n1. Active chronic diarrheal illness (eg, Crohn's disease, ulcerative colitis, short bowel syndrome)\n2. Previous adverse reactions to oral vancomycin\n3. Requiring metronidazole during hospitalization\n4. Known pregnancy\n5. Expected survival \\<72 hours\n6. Patients receiving antibiotics only for surgical prophylaxis\n7. Patients who received prophylactic oral vancomycin for the current antibiotic course prior to enrollment in the study"}, 'identificationModule': {'nctId': 'NCT03466502', 'briefTitle': 'Oral Vancomycin to Prevent Recurrent C Difficile Infection With Antibiotics', 'organization': {'class': 'OTHER', 'fullName': 'University of Nevada, Reno'}, 'officialTitle': 'Efficacy of Prophylactic Oral Vancomycin in Preventing Recurrent Clostridium Difficile Infection in Hospitalized Patients Requiring Antibiotics', 'orgStudyIdInfo': {'id': '1129396'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No oral vancomycin'}, {'type': 'EXPERIMENTAL', 'label': 'Oral vancomycin 125 mg twice daily', 'interventionNames': ['Drug: Oral Vancomycin']}, {'type': 'EXPERIMENTAL', 'label': 'Oral vancomycin 125 mg daily', 'interventionNames': ['Drug: Oral Vancomycin']}], 'interventions': [{'name': 'Oral Vancomycin', 'type': 'DRUG', 'description': 'Oral vancomycin will be given concurrently with antibiotics to hospitalized patients with a history of Clostridium difficile infection to prevent recurrence', 'armGroupLabels': ['Oral vancomycin 125 mg daily', 'Oral vancomycin 125 mg twice daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Renown Regional Medical Center', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}], 'overallOfficials': [{'name': 'Lauren Zion, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Renown Regional Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nevada, Reno', 'class': 'OTHER'}, 'collaborators': [{'name': 'Renown Regional Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pharmacist', 'investigatorFullName': 'Lauren Zion, PharmD', 'investigatorAffiliation': 'University of Nevada, Reno'}}}}