Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-28 @ 6:46 PM
Study NCT ID:
NCT00876850
Status:
WITHDRAWN
Last Update Posted:
2012-05-09
First Post:
2009-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018461', 'term': 'Soft Tissue Infections'}, {'id': 'D000038', 'term': 'Abscess'}, {'id': 'D002481', 'term': 'Cellulitis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545884', 'term': '7-dimethylamino-9-(2,2-dimethylpropyl)aminomethylcycline'}, {'id': 'D000069349', 'term': 'Linezolid'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, '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': 0}}, 'statusModule': {'whyStopped': 'Terminated', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2010-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-08', 'studyFirstSubmitDate': '2009-04-06', 'studyFirstSubmitQcDate': '2009-04-06', 'lastUpdatePostDateStruct': {'date': '2012-05-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical success at follow-up', 'timeFrame': '4 weeks after enrollment'}], 'secondaryOutcomes': [{'measure': 'To evaluate safety of dosing regimens', 'timeFrame': '4 weeks after enrollment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cSSI', 'Abscess', 'Would', 'Cellulitis', 'Complicated Skin and Skin Structure Infections (cSSSI)'], 'conditions': ['Skin Structures and Soft Tissue Infections']}, 'descriptionModule': {'briefSummary': 'A Phase III trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).', 'detailedDescription': 'The pharmacologic profile of PTK 0796 in humans suggests that it has the potential to be used safely and effectively for this indication. Data from in vitro and animal studies support this hypothesis.\n\nIn PTK 0796-CSSI-0805 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic approved for this indication by the FDA. Initial treatment will be administered intravenously with the option for subsequent oral treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has and acute complicated skin and skin structure infection with findings of systemic inflammatory response\n* Patients, ages 18 years or older\n* Is expected to require greater than or equal to 4 days antibiotic therapy\n* Female patients must not be pregnant at the time of enrollment and must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug\n\nExclusion Criteria:\n\n* Has received an investigational drug within the past 1 month\n* Has been previously enrolled in this protocol\n* Has received \\>48hr of potentially effective systemic antibiotic immediately prior to study drug\n* Is nursing'}, 'identificationModule': {'nctId': 'NCT00876850', 'briefTitle': 'Phase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Paratek Pharmaceuticals Inc'}, 'officialTitle': 'A Randomized, Evaluator-Blinded, Phase 3 Study to Compare the Safety and Efficacy of PTK 0796 With Linezolid in the Treatment of Adults With Complicated Skin and Skin Structure Infection', 'orgStudyIdInfo': {'id': 'PTK 0796-CSSI-0805'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PTK 0796', 'description': 'PTK 0796 100mg for injection; PTK 0796 tablet 150mg', 'interventionNames': ['Drug: PTK 0796']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Linezolid', 'description': 'For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600mg IV infusion solution; For gram negative treatment: Moxifloxacin 400 mg tablets and pre-mixed 400mg IV infusion solution', 'interventionNames': ['Drug: Linezolid']}], 'interventions': [{'name': 'PTK 0796', 'type': 'DRUG', 'description': 'PTK 0796 100mg for injection; PTK 0796 tablet 150mg', 'armGroupLabels': ['PTK 0796']}, {'name': 'Linezolid', 'type': 'DRUG', 'otherNames': ['Zyvox™; Avelox™'], 'description': 'For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600mg IV infusion solution; For gram negative treatment: Moxifloxacin 400mg tablets and pre-mixed 400mg IV infusion solution', 'armGroupLabels': ['Linezolid']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Robert Arbeit, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Paratek Pharmaceuticals Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paratek Pharmaceuticals Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}