Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
Study NCT ID:
NCT00343135
Status:
COMPLETED
Last Update Posted:
2012-11-22
First Post:
2006-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AUGMENTIN 1gm In Skin And Soft Tissue Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D018461', 'term': 'Soft Tissue Infections'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000658', 'term': 'Amoxicillin'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 195}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-21', 'studyFirstSubmitDate': '2006-06-20', 'studyFirstSubmitQcDate': '2006-06-20', 'lastUpdatePostDateStruct': {'date': '2012-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical response at 10 - 14 days post therapy', 'timeFrame': '10 - 14 days'}], 'secondaryOutcomes': [{'measure': 'Clinical response at on-therapy evaluation visit (2 - 4 days following initiation of therapy and 48 - 96 hours post therapy) Bacteriological response at (2 - 4 days following initiation of therapy, 48 - 96 hours post therapy, 10 - 14 days post therapy)', 'timeFrame': '2 - 4 days'}]}, 'conditionsModule': {'keywords': ['Skin', 'AUGMENTIN', '1gm', 'Soft', 'tissue', 'Infections'], 'conditions': ['Skin Diseases, Infectious', 'Infection, Soft Tissue']}, 'descriptionModule': {'briefSummary': 'Study to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue infections'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* having diagnosed uncomplicated soft tissue infection (e.g furuncle, cellulitis)\n* has given freely documented consent.\n\nExclusion Criteria:\n\n* antibiotics\n* have renal or hepatic insufficiency\n* systemic toxicity\n* pregnancy\n* lactation\n* hypersensitivity to penicillin or Beta-lactam antibiotics'}, 'identificationModule': {'nctId': 'NCT00343135', 'briefTitle': 'AUGMENTIN 1gm In Skin And Soft Tissue Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Open, Non-comparative Study to Evaluate the Efficacy and Safety of AUGMENTIN 1gm (875mg Amoxicillin/125mg Clavulanic Acid) po q 12 Hours in the Treatment of Uncomplicated Skin and Soft Tissue Infections in Pakistan', 'orgStudyIdInfo': {'id': '103997'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARM 1', 'interventionNames': ['Drug: amoxicillin/clavulanate potassium 1gm']}], 'interventions': [{'name': 'amoxicillin/clavulanate potassium 1gm', 'type': 'DRUG', 'description': 'amoxicillin/clavulanate potassium 1gm', 'armGroupLabels': ['ARM 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'country': 'Pakistan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '54000', 'city': 'Lahore', 'country': 'Pakistan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'city': 'Lahore', 'country': 'Pakistan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}