Ignite Creation Date:
2025-12-25 @ 4:45 AM
Ignite Modification Date:
2026-03-01 @ 5:20 PM
Study NCT ID:
NCT02607618
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2015-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018461', 'term': 'Soft Tissue Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C486448', 'term': 'iclaprim'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stephanie.noviello@motifbio.com', 'phone': '908-432-7802', 'title': 'Stephanie Noviello', 'organization': 'Motif BioSciences'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 month', 'eventGroups': [{'id': 'EG000', 'title': 'Iclaprim', 'description': 'iclaprim 80 mg intravenous every 12 hours\n\nIclaprim: Experimental treatment', 'otherNumAtRisk': 299, 'deathsNumAtRisk': 299, 'otherNumAffected': 0, 'seriousNumAtRisk': 299, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vancomycin', 'description': 'vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance\n\nVancomycin: Active comparator', 'otherNumAtRisk': 302, 'deathsNumAtRisk': 302, 'otherNumAffected': 1, 'seriousNumAtRisk': 302, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Product Issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Renal and urinary disorders', 'notes': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Participants With ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iclaprim', 'description': 'iclaprim 80 mg intravenous every 12 hours\n\nIclaprim: Experimental treatment'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance\n\nVancomycin: Active comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '78.3', 'groupId': 'OG000', 'lowerLimit': '73.2', 'upperLimit': '82.9'}, {'value': '76.7', 'groupId': 'OG001', 'lowerLimit': '71.6', 'upperLimit': '81.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 48 to 72 hours after first dose of study drug', 'description': '≥20% reduction in lesion size at 48 to 72 hours (Early Time Point \\[ETP\\]) compared to baseline in all randomized patients (ITT).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Resolution or Near Resolution of Lesion at Test of Cure Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iclaprim', 'description': 'iclaprim 80 mg intravenous every 12 hours\n\nIclaprim: Experimental treatment'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance\n\nVancomycin: Active comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '229', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 to14 days after the end of treatment', 'description': 'Resolution or Near Resolution of Lesion at Test of Cure (TOC) Visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Iclaprim', 'description': 'iclaprim 80 mg intravenous every 12 hours\n\nIclaprim: Experimental treatment'}, {'id': 'FG001', 'title': 'Vancomycin', 'description': 'vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance\n\nVancomycin: Active comparator'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '306'}, {'groupId': 'FG001', 'numSubjects': '307'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '295'}, {'groupId': 'FG001', 'numSubjects': '305'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'BG000'}, {'value': '305', 'groupId': 'BG001'}, {'value': '600', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Iclaprim', 'description': 'iclaprim 80 mg intravenous every 12 hours\n\nIclaprim: Experimental treatment'}, {'id': 'BG001', 'title': 'Vancomycin', 'description': 'vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance\n\nVancomycin: Active comparator'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '240', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '490', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'spread': '15.7', 'groupId': 'BG000'}, {'value': '50.8', 'spread': '15.0', 'groupId': 'BG001'}, {'value': '50.4', 'spread': '15.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '267', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '543', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Turkey', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '405', 'groupId': 'BG002'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Estonia', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}, {'title': 'Croatia', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-12-03', 'size': 2691364, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-06-14T11:58', 'hasProtocol': True}, {'date': '2017-07-24', 'size': 5620082, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-06-14T12:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 613}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-10', 'studyFirstSubmitDate': '2015-11-13', 'resultsFirstSubmitDate': '2018-06-14', 'studyFirstSubmitQcDate': '2015-11-16', 'lastUpdatePostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-14', 'studyFirstPostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Participants With ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline', 'timeFrame': 'Baseline and 48 to 72 hours after first dose of study drug', 'description': '≥20% reduction in lesion size at 48 to 72 hours (Early Time Point \\[ETP\\]) compared to baseline in all randomized patients (ITT).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Resolution or Near Resolution of Lesion at Test of Cure Visit', 'timeFrame': '7 to14 days after the end of treatment', 'description': 'Resolution or Near Resolution of Lesion at Test of Cure (TOC) Visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Skin Structures and Soft Tissue Infections']}, 'referencesModule': {'references': [{'pmid': '29783024', 'type': 'DERIVED', 'citation': "Huang DB, Corey GR, Holland TL, Lodise T, O'Riordan W, Wilcox MH, File TM Jr, Dryden M, Balser B, Desplats E, Torres A. Pooled analysis of the phase 3 REVIVE trials: randomised, double-blind studies to evaluate the safety and efficacy of iclaprim versus vancomycin for treatment of acute bacterial skin and skin-structure infections. Int J Antimicrob Agents. 2018 Aug;52(2):233-240. doi: 10.1016/j.ijantimicag.2018.05.012. Epub 2018 May 19."}, {'pmid': '29530858', 'type': 'DERIVED', 'citation': "Holland TL, O'Riordan W, McManus A, Shin E, Borghei A, File TM Jr, Wilcox MH, Torres A, Dryden M, Lodise T, Oguri T, Corey GR, McLeroth P, Shukla R, Huang DB. A Phase 3, Randomized, Double-Blind, Multicenter Study To Evaluate the Safety and Efficacy of Intravenous Iclaprim versus Vancomycin for Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed To Be Due to Gram-Positive Pathogens (REVIVE-2 Study). Antimicrob Agents Chemother. 2018 Apr 26;62(5):e02580-17. doi: 10.1128/AAC.02580-17. Print 2018 May."}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin for the treatment of skin and skin structure infections.', 'detailedDescription': 'This is a multicenter, randomized, double-blind study of the efficacy and safety of IV iclaprim compared to IV vancomycin. Patients will receive either iclaprim or vancomycin for 5 to 14 days. Patients will be evaluated daily up to early time point (ETP), then every 48 to 72 hours through the end of treatment. Patients will also be evaluated at the test of cure (TOC) visit (7 to 14 days post-EOT), and will have a Late Follow-Up (LFU) visit (28 to 32 days post-first dose).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. written informed consent;\n2. ≥18 years of age;\n3. a bacterial infection of the skin with a lesion size area of at least 75 cm2;\n4. a major cutaneous abscess, cellulitis/erysipelas, and/or wound infections;\n5. the presence of purulent or seropurulent drainage or at least three signs and symptoms of infection (discharge, erythema, swelling, warmth, or pain).\n\nExclusion Criteria:\n\n1. severely impaired arterial blood supply such that amputation of the infected anatomical site is likely;\n2. infected diabetic foot ulcers;\n3. infected decubitus ulcers;\n4. necrotizing fasciitis or gangrene;\n5. uncomplicated skin or skin structure infection;\n6. infections associated with a prosthetic device;\n7. suspected or confirmed osteomyelitis;\n8. conditions requiring systemic anti-microbial treatment, prophylaxis, or suppression therapy.'}, 'identificationModule': {'nctId': 'NCT02607618', 'acronym': 'REVIVE-2', 'briefTitle': 'Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-2', 'organization': {'class': 'INDUSTRY', 'fullName': 'Motif Bio'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim Versus Vancomycin in the Treatment of ABSSSI: REVIVE-2', 'orgStudyIdInfo': {'id': 'ICL-24-ABSSSI2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iclaprim', 'description': 'iclaprim 80 mg intravenous every 12 hours', 'interventionNames': ['Drug: Iclaprim']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'vancomycin', 'description': 'vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance', 'interventionNames': ['Drug: Vancomycin']}], 'interventions': [{'name': 'Iclaprim', 'type': 'DRUG', 'otherNames': ['MTF-100'], 'description': 'Experimental treatment', 'armGroupLabels': ['iclaprim']}, {'name': 'Vancomycin', 'type': 'DRUG', 'otherNames': ['Vancocin'], 'description': 'Active comparator', 'armGroupLabels': ['vancomycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92804', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'California', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90620', 'city': 'Buena Park', 'state': 'California', 'country': 'United States', 'facility': 'California', 'geoPoint': {'lat': 33.86751, 'lon': -117.99812}}, {'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'California', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '90623', 'city': 'La Palma', 'state': 'California', 'country': 'United 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