Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-28 @ 5:02 PM
Study NCT ID:
NCT03107169
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2017-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Initial Clostridium Difficile Infection
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': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}, {'id': 'D014640', 'term': 'Vancomycin'}, {'id': 'D006020', 'term': 'Glycopeptides'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patients were randomized by a closed envelope method in a 1: 1 ratio to either oral vancomycin (every 6 h for 10-14 days) or a FMT-FURM'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-15', 'studyFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2017-04-10', 'lastUpdatePostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease in number of evacuations', 'timeFrame': 'up to a 2 days', 'description': 'The cure of CDI was measured'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clostridium Difficile Infection']}, 'descriptionModule': {'briefSummary': 'Investigators designed an open, two-arm study to compare oral vancomycin with a fecal microbiota transplant (FMT) from a fecal donor-unrelated donor mix (FURM) as treatments for the first Clostridium difficile infection (CDI) episode among hospitalized patients.', 'detailedDescription': 'Investigators designed an open, two-arm study to compare oral vancomycin with an FMT-FURM as treatments for the first Clostridium difficile infection (CDI) episode among hospitalized patients. From each patient, a fecal sample was obtained at days 0, 3, and 7 after treatment. Specimens are cultured to isolate C. difficile, and C. difficile are assessed for the presence of genes encoding enterotoxin (tcdB), cytotoxin (tcdA), the binary toxin A (cdtA), binary toxin B (cdtB), and deletions within the negative regulator of toxin A and B production (tcdC) by polymerase chain reaction (PCR). The minimum inhibitory concentrations (MICs) of ciprofloxacin, moxifloxacin, erythromycin, clindamycin, vancomycin, metronidazole, linezolid, fidaxomicin, and tetracycline against C. difficile are measured using the agar dilution method. Fecal samples and FMT-FURM are analyzed by 16 subunit ribosomal ribonucleic acid (16S rRNA) metagenomic sequencing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of CDI (first episode)\n* Older than 18 years old\n\nExclusion Criteria:\n\n* Patients younger than 18 years old'}, 'identificationModule': {'nctId': 'NCT03107169', 'briefTitle': 'Treatment of Initial Clostridium Difficile Infection', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Autonoma de Nuevo Leon'}, 'officialTitle': 'Fecal Microbiota Transplant Versus Vancomycin for Treatment of Initial Clostridium Difficile Infection', 'orgStudyIdInfo': {'id': 'IF14-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vancomycin', 'description': 'Patients in this arm received vancomycin 250mg every 6 hrs for 10-14 days', 'interventionNames': ['Drug: Vancomycin']}, {'type': 'EXPERIMENTAL', 'label': 'FMT-FURM', 'description': 'Patients in this arm receive FMT-FURM', 'interventionNames': ['Other: FMT']}], 'interventions': [{'name': 'FMT', 'type': 'OTHER', 'otherNames': ['fecal microbiota transplant'], 'description': 'Patients in the FMT group received FMT-FURM', 'armGroupLabels': ['FMT-FURM']}, {'name': 'Vancomycin', 'type': 'DRUG', 'otherNames': ['Glycopeptide'], 'description': 'Patients in the vancomycin group received oral vancomycin (250 mg every 6 h for 10-14 days)', 'armGroupLabels': ['Vancomycin']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Autonoma de Nuevo Leon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Adrián Camacho-Ortiz', 'investigatorAffiliation': 'Universidad Autonoma de Nuevo Leon'}}}}