Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-27 @ 7:08 AM
Study NCT ID:
NCT00822692
Status:
COMPLETED
Last Update Posted:
2015-12-21
First Post:
2009-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000038', 'term': 'Abscess'}, {'id': 'D002481', 'term': 'Cellulitis'}], 'ancestors': [{'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D007239', 'term': 'Infections'}, {'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': 'D015662', 'term': 'Trimethoprim, Sulfamethoxazole Drug Combination'}], 'ancestors': [{'id': 'D013420', 'term': 'Sulfamethoxazole'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D014295', 'term': 'Trimethoprim'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gillianmd@gmail.com', 'phone': '919-724-9185', 'title': 'Gillian Schmitz, MD', 'organization': 'Wilford Hall Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Bactrim DS (800/160) Two Tablets PO BID x 7 Days', 'description': 'bactrim DS (800/160) two tablets PO BID x 7 days', 'otherNumAtRisk': 63, 'otherNumAffected': 15, 'seriousNumAtRisk': 63, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Matched Placebo 2 Pills PO BID x 7 Days', 'description': 'matched placebo 2 pills PO BID x 7 days', 'otherNumAtRisk': 76, 'otherNumAffected': 27, 'seriousNumAtRisk': 76, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'treatment failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 27}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Recurrence Rates of Abscesses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bactrim DS (800/160) Two Tablets PO BID x 7 Days', 'description': 'Active Intervention Arm'}, {'id': 'OG001', 'title': 'Matched Placebo 2 Pills PO BID x 7 Days', 'description': 'Placebo arm'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after incision and drainage', 'description': 'Number of patient with a new abscess in same or different location as previous lesion', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bactrim DS (800/160) Two Tablets PO BID x 7 Days', 'description': 'Active Intervention Arm'}, {'id': 'FG001', 'title': 'Matched Placebo 2 Pills PO BID x 7 Days', 'description': 'Placebo arm'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'July 1, 2008', 'groupId': 'FG000', 'numSubjects': '63'}, {'comment': 'July 1, 2008', 'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'June 1, 2009', 'groupId': 'FG000', 'numSubjects': '46'}, {'comment': 'June 1 , 2009', 'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '25'}]}]}], 'recruitmentDetails': 'Patients were enrolled at 3 hospital emergency departments from July 1, 2008 to June 1, 2009.', 'preAssignmentDetails': 'Patients were assigned by block randomization and data was analyzed with intention to treat analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bactrim DS (800/160) Two Tablets PO BID x 7 Days', 'description': 'Active Intervention Arm'}, {'id': 'BG001', 'title': 'Matched Placebo 2 Pills PO BID x 7 Days', 'description': 'Placebo arm'}, {'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': '63', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.6', 'spread': '13', 'groupId': 'BG000'}, {'value': '30.6', 'spread': '13', 'groupId': 'BG001'}, {'value': '31.06', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-17', 'studyFirstSubmitDate': '2009-01-13', 'resultsFirstSubmitDate': '2009-07-29', 'studyFirstSubmitQcDate': '2009-01-13', 'lastUpdatePostDateStruct': {'date': '2015-12-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-07-29', 'studyFirstPostDateStruct': {'date': '2009-01-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence Rates of Abscesses', 'timeFrame': '30 days after incision and drainage', 'description': 'Number of patient with a new abscess in same or different location as previous lesion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Abscess', 'Cellulitis', 'Antibiotics', 'MRSA'], 'conditions': ['Abscess', 'Methicillin-Resistant Staphylococcus Aureus Infection']}, 'referencesModule': {'references': [{'pmid': '20346539', 'type': 'DERIVED', 'citation': 'Schmitz GR, Bruner D, Pitotti R, Olderog C, Livengood T, Williams J, Huebner K, Lightfoot J, Ritz B, Bates C, Schmitz M, Mete M, Deye G. Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated skin abscesses in patients at risk for community-associated methicillin-resistant Staphylococcus aureus infection. Ann Emerg Med. 2010 Sep;56(3):283-7. doi: 10.1016/j.annemergmed.2010.03.002. Epub 2010 Mar 26.'}]}, 'descriptionModule': {'briefSummary': 'Patients will be enrolled in a multi-center study (Wilford Hall Medical Center and Brooke Army Medical Center) to prospectively evaluate outcome after treatment for an uncomplicated skin abscess.', 'detailedDescription': 'All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1) septa double strength two pills orally twice a day x 7 days or 2)placebo. Patients will then return to the emergency room on days 3 and 7 for wound repacking and evaluation. The primary outcome recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics if needed. Data will be analyzed both by initial randomization and intention to treat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients age 18-65 who present to the emergency department with a skin abscess that requires incision and drainage.\n\nExclusion Criteria:\n\n* Patients with diabetes, HIV, cancer or other immunocompromised patients.\n* Additionally, any patients who received antibiotics within one week of presentation or were hospitalized in previous month will be excluded to minimize potential confounding variables.\n* Pregnant and breastfeeding patients will also be excluded due to possible safety concerns with antibiotic treatment.\n* Patients with abscesses on head, face, perirectal, or periananal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded.\n* Finally, patients with sulfa allergy will be excluded.'}, 'identificationModule': {'nctId': 'NCT00822692', 'briefTitle': 'Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection', 'organization': {'class': 'FED', 'fullName': '59th Medical Wing'}, 'officialTitle': 'Prospective Randomized Double Blind, Placebo-Controlled Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection on 30 Day Recurrence Rates.', 'orgStudyIdInfo': {'id': 'FWH20080055H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bactrim DS', 'description': 'Trim/sulfa (800/160) two tablets orally (PO) twice a day (BID) x 7 days', 'interventionNames': ['Drug: Trim/ Sulfa DS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'matched placebo', 'description': 'matched placebo 2 pills orally (PO) twice a day (BID) x 7 days', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Trim/ Sulfa DS', 'type': 'DRUG', 'otherNames': ['Bactrim'], 'description': 'bactrim DS (800/160) two tablets PO BID x 7 days', 'armGroupLabels': ['Bactrim DS']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'matched placebo 2 pills PO BID x 7 days', 'armGroupLabels': ['matched placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78236', 'city': 'Lackland Air Force Base', 'state': 'Texas', 'country': 'United States', 'facility': 'Wilford Hall Medical Center', 'geoPoint': {'lat': 29.38663, 'lon': -98.61797}}], 'overallOfficials': [{'name': 'Gillian R Schmitz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '59th Medical Wing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '59th Medical Wing', 'class': 'FED'}, 'collaborators': [{'name': 'U.S. Air Force Office of the Surgeon General', 'class': 'FED'}, {'name': 'Emergency Medicine Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Emergency Physician', 'investigatorFullName': 'Gillian Schmitz', 'investigatorAffiliation': '59th Medical Wing'}}}}