Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-02-22 @ 5:08 PM
Study NCT ID:
NCT02692651
Status:
COMPLETED
Last Update Posted:
2022-03-25
First Post:
2016-02-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077732', 'term': 'Fidaxomicin'}, {'id': 'C487655', 'term': 'OPT 80'}, {'id': 'D014640', 'term': 'Vancomycin'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'krirao@med.umich.edu', 'phone': '734 615-9730', 'title': 'Krishna Rao', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Treatment period + 30 days, ranging from a total of 40 to 114 days.', 'description': 'Adverse events collected with follow-up surveys and by clinical alerts.', 'eventGroups': [{'id': 'EG000', 'title': 'Fidaxomicin', 'description': 'Fidaxomicin pill 200 mg PO 2 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 0, 'seriousNumAtRisk': 74, 'deathsNumAffected': 7, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Vancomycin', 'description': 'Vancomycin solution 125 mg PO 4 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 0, 'seriousNumAtRisk': 70, 'deathsNumAffected': 11, 'seriousNumAffected': 13}], 'seriousEvents': [{'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Cure: Resolution of Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fidaxomicin', 'description': 'Fidaxomicin pill 200 mg PO 2 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Vancomycin solution 125 mg PO 4 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.195', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'length of treatment plus 2 days, from a minimum of 12 to a maximum of 86 days', 'description': 'Resolution of diarrhea defined as ≤ 3 unformed stools for 2 consecutive days maintained until the end of therapy and for 2 days afterwards. The treatment course was at least 10 days, but it could be extended to a maximum of 12 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis'}, {'type': 'SECONDARY', 'title': 'Recurrence of CDI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fidaxomicin', 'description': 'Fidaxomicin pill 200 mg PO 2 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Vancomycin solution 125 mg PO 4 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.99', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "30 days after treatment's end (maximum of 114 days)", 'description': 'Recurrence is defined as all three of the following within 4 weeks after successfully completing study treatment: reappearance of symptoms of CDI (\\>3 unformed stools in a 24 hour period; a positive stool PCR test for C. difficile; and the need for retreatment with an agent active against C. difficile).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who completed study treatment and were alive at the end of 30-day follow-up.'}, {'type': 'SECONDARY', 'title': '30-day Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fidaxomicin', 'description': 'Fidaxomicin pill 200 mg PO 2 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Vancomycin solution 125 mg PO 4 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.999', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '40 to 114 days', 'description': 'Death in subjects who completed the study treatment and died within 30 days after end of treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who completed the study treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vancomycin', 'description': 'Vancomycin solution 125 mg PO 4 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.'}, {'id': 'FG001', 'title': 'Fidaxomicin', 'description': 'Fidaxomicin pill 200 mg PO 2 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.'}], 'periods': [{'title': 'Study Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'comfort care', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol violation per treating team preference', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}, {'title': 'Post Study Treatment Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fidaxomicin', 'description': 'Fidaxomicin pill 200 mg PO 2 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.'}, {'id': 'BG001', 'title': 'Vancomycin', 'description': 'Vancomycin solution 125 mg PO 4 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<65', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}, {'title': '65-74', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': '>74', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26.7', 'groupId': 'BG000', 'lowerLimit': '15.5', 'upperLimit': '48.2'}, {'value': '28.2', 'groupId': 'BG001', 'lowerLimit': '15.2', 'upperLimit': '51.3'}, {'value': '27.4', 'groupId': 'BG002', 'lowerLimit': '15.2', 'upperLimit': '51.3'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Patients in ICU at enrollment', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of patients who were in the Intensive Care Unit (ICU) when enrolled.', 'unitOfMeasure': 'Participants'}, {'title': 'History of C difficile infection', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of cancer', 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of stem cell transplant', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of inflammatory bowel disease', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of Proton Pump Inhibitors use', 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'White blood cell count', 'classes': [{'categories': [{'measurements': [{'value': '9.46', 'groupId': 'BG000', 'lowerLimit': '0.1', 'upperLimit': '33.5'}, {'value': '7.93', 'groupId': 'BG001', 'lowerLimit': '0.1', 'upperLimit': '36.3'}, {'value': '8.7', 'groupId': 'BG002', 'lowerLimit': '0.1', 'upperLimit': '36.3'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '1000 cells/μL', 'dispersionType': 'FULL_RANGE'}, {'title': 'Creatinine', 'classes': [{'categories': [{'measurements': [{'value': '1.11', 'groupId': 'BG000', 'lowerLimit': '0.26', 'upperLimit': '3.27'}, {'value': '1.36', 'groupId': 'BG001', 'lowerLimit': '0.42', 'upperLimit': '5.36'}, {'value': '1.23', 'groupId': 'BG002', 'lowerLimit': '0.26', 'upperLimit': '5.36'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-04', 'size': 338476, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-02-23T14:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-24', 'studyFirstSubmitDate': '2016-02-23', 'resultsFirstSubmitDate': '2022-02-23', 'studyFirstSubmitQcDate': '2016-02-23', 'lastUpdatePostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-24', 'studyFirstPostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Cure: Resolution of Diarrhea', 'timeFrame': 'length of treatment plus 2 days, from a minimum of 12 to a maximum of 86 days', 'description': 'Resolution of diarrhea defined as ≤ 3 unformed stools for 2 consecutive days maintained until the end of therapy and for 2 days afterwards. The treatment course was at least 10 days, but it could be extended to a maximum of 12 weeks.'}], 'secondaryOutcomes': [{'measure': 'Recurrence of CDI', 'timeFrame': "30 days after treatment's end (maximum of 114 days)", 'description': 'Recurrence is defined as all three of the following within 4 weeks after successfully completing study treatment: reappearance of symptoms of CDI (\\>3 unformed stools in a 24 hour period; a positive stool PCR test for C. difficile; and the need for retreatment with an agent active against C. difficile).'}, {'measure': '30-day Mortality', 'timeFrame': '40 to 114 days', 'description': 'Death in subjects who completed the study treatment and died within 30 days after end of treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vancomycin', 'fidaxomicin', 'CDI', 'diarrhea'], 'conditions': ['Clostridium Difficile Infection (CDI)']}, 'referencesModule': {'references': [{'pmid': '37797310', 'type': 'DERIVED', 'citation': 'Rao K, Zhao Q, Bell J, Krishnan J, Henig O, Daniel J, Sawaya K, Albin O, Mills JP, Petty LA, Gregg K, Kaul D, Malani AN, Pogue J, Kaye KS. An Open-Label, Randomized Trial Comparing Fidaxomicin With Oral Vancomycin for the Treatment of Clostridioides difficile Infection in Hospitalized Patients Receiving Concomitant Antibiotics for Concurrent Infections. Clin Infect Dis. 2024 Feb 17;78(2):277-282. doi: 10.1093/cid/ciad606.'}]}, 'descriptionModule': {'briefSummary': 'Administration of concomitant antibiotics (CA) is a known risk factor for treatment failure in the treatment of CDI, as well as for recurrence of CDI. Recent data suggested that among patients receiving CA, fidaxomicin is superior to vancomycin. While these data are encouraging, many clinicians remain unclear on how to apply these data to patient care. Additionally, patients were excluded from the trials presented to the FDA if it was expected that they would require ≥ 7 days of CA. Therefore, the clinical question still remains of how to apply these data to the real world patient who requires a long course of CA and develops CDI while on therapy. We therefore propose an open label, comparative and prospective study of fidaxomicin 200 mg twice daily vs oral vancomycin 125 mg four times daily for the treatment of CDI among patients who are receiving a long course of CA.\n\nWe hypothesize that fidaxomicin will be superior to vancomycin with respect to clinical cure for patients with CDI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years of age or older with \\>3 unformed stools/24 hours with positive stool test for C. difficile.\n* Patients receiving ≥ 1 high or medium risk antibiotic for treatment of an infection other than CDI, for an anticipated duration of ≥ 5 days from the time of enrollment.\n\n * High risk: carbapenems, 2nd-4th generation cephalosporins, fluoroquinolones, clindamycin, and beta-lactam/beta-lactamase inhibitor combinations\n * Medium risk: 1st generation cephalosporin, macrolides\\*, and aztreonam\n\n * \\*The macrolide would be considered to be low risk if patients are receiving intermittent macrolides for prophylaxis only and not for treatment of an acute infection\n\nExclusion Criteria:\n\n* Patients with severe-complicated disease that would compromise oral therapy (hypotenstion or shock, ileus or bowel obstruction, megacolon).\n* Patients with an allergy to oral vancomycin or fidaxomicin.\n* Patients anticipated to receive metronidazole after enrollment.\n* Patients who already received oral vancomycin or metronidazole (either oral or intravenous) for \\> 24 hours within the preceding 72 hours at the time of enrollment.\n* Patients anticipated to receive adjunctive C. difficile therapy (rifaxamin, nitazoxanide, tigecycline) after enrollment.\n* Patients who are on laxatives before they are enrolled into the study, such as lactulose, if:\n\n * Patients have had a recent dose adjustment;\n * Baseline number of bowel movement while on laxatives is unknown.\n * Number of bowel movements and/or consistency has not changed from baseline.\n* Patients who have had colostomy or ileostomy\n* Patients who will have colostomy or ileostomy after enrollment and before study ends\n* Patients who are or will be on long-term (\\>12 weeks) medium or high-risk antibiotics prophylaxis after enrollment'}, 'identificationModule': {'nctId': 'NCT02692651', 'briefTitle': 'A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'A Comparison of Fidaxomicin and Oral Vancomycin for the Treatment of Clostridium Difficile Infection (CDI) in Hospitalized Patients Receiving Concomitant Antibiotics for the Treatment of Concurrent Systemic Infections', 'orgStudyIdInfo': {'id': 'Merck Fidaxo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fidaxomicin', 'description': 'Fidaxomicin 200 mg PO BID for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.', 'interventionNames': ['Drug: Fidaxomicin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vancomycin', 'description': 'Vancomycin 125 mg PO QID for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.', 'interventionNames': ['Drug: Vancomycin']}], 'interventions': [{'name': 'Fidaxomicin', 'type': 'DRUG', 'otherNames': ['Dificid, Dificlir, OPT-80, PAR-101'], 'description': 'Eligible patients randomized to receive open-label Fidaxomicin will receive 200 mg twice daily for 10 days or until the end of the duration of concomitant antibiotics exposure, whichever is longer.', 'armGroupLabels': ['Fidaxomicin']}, {'name': 'Vancomycin', 'type': 'DRUG', 'otherNames': ['Vancocin'], 'description': 'Eligible patients randomized to Vancomycin will receive 125 mg orally four times daily for 10 days or until the end of the duration of concomitant antibiotics exposure, whichever is longer.', 'armGroupLabels': ['Vancomycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48197', 'city': 'Ypsilanti', 'state': 'Michigan', 'country': 'United States', 'facility': 'St. Joseph Mercy Hospital', 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}], 'overallOfficials': [{'name': 'A. Krishna Rao, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Internal Medicine', 'investigatorFullName': 'Krishna Rao', 'investigatorAffiliation': 'University of Michigan'}}}}