Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-18 @ 12:28 PM
Study NCT ID:
NCT02024867
Status:
COMPLETED
Last Update Posted:
2015-10-19
First Post:
2013-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of 3 Versus 10 Days of Antibiotics in Skin Abscesses After Surgical Drainage
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D000038', 'term': 'Abscess'}, {'id': 'D013203', 'term': 'Staphylococcal Infections'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}]}, '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': 'LHolmes@upa.chob.edu', 'phone': '716-878-7277', 'title': 'Dr. Lucy Holmes', 'organization': 'University at Buffalo'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2.5 years', 'eventGroups': [{'id': 'EG000', 'title': '3 Days', 'description': 'Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day', 'otherNumAtRisk': 125, 'otherNumAffected': 0, 'seriousNumAtRisk': 125, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '10 Days', 'description': 'Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day', 'otherNumAtRisk': 124, 'otherNumAffected': 0, 'seriousNumAtRisk': 124, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Failures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3 Days', 'description': 'Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day'}, {'id': 'OG001', 'title': '10 Days', 'description': 'Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.0', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '9.5', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The sample size of 120 per group was calculated according to an assumed treatment cure rate of 95% with 10 days of antibiotics, and a non-inferiority margin of 7% (allowing up to 88% cure rate with 3 days of antibiotics), to achieve a power of 0.80 (alpha=0.05). An additional 25 patients were recruited to account for an estimated 10% lost to follow-up.'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 weeks after surgical drainage', 'description': 'Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Recurrent Skin Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3 Days', 'description': 'Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day'}, {'id': 'OG001', 'title': '10 Days', 'description': 'Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.7', 'ciLowerLimit': '2.1', 'ciUpperLimit': '19.2', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'described previously'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after surgical drainage', 'description': 'Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3 Days', 'description': 'Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day'}, {'id': 'OG001', 'title': '10 Days', 'description': 'Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.1', 'ciLowerLimit': '2.1', 'ciUpperLimit': '18.2', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'described previously'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 weeks after surgical drainage', 'description': 'Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3 Days', 'description': 'Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day'}, {'id': 'OG001', 'title': '10 Days', 'description': 'Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-6.9', 'ciUpperLimit': '7.0', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'described previously'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 2 weeks after surgical drainage', 'description': 'Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3 Days', 'description': 'Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day'}, {'id': 'OG001', 'title': '10 Days', 'description': 'Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.046', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.3', 'ciLowerLimit': '0.8', 'ciUpperLimit': '19.9', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'described previously'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after surgical drainage', 'description': 'Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3 Days', 'description': 'Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day'}, {'id': 'OG001', 'title': '10 Days', 'description': 'Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'described previously'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after surgical drainage', 'description': 'Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '3 Days', 'description': 'Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day'}, {'id': 'FG001', 'title': '10 Days', 'description': 'Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}, {'groupId': 'FG001', 'numSubjects': '131'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '124'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '3 Days', 'description': 'Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day'}, {'id': 'BG001', 'title': '10 Days', 'description': 'Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'BG000', 'lowerLimit': '0.5', 'upperLimit': '17'}, {'value': '3.42', 'groupId': 'BG001', 'lowerLimit': '0.33', 'upperLimit': '17'}, {'value': '4.08', 'groupId': 'BG002', 'lowerLimit': '0.33', 'upperLimit': '17'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '63', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Abscess location', 'classes': [{'title': 'Abscess below the waist', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}]}, {'title': 'Abscess above the waist', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': 'Abscess both locations', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'presence of fever', 'classes': [{'title': 'fever', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'no fever', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'presence of cellulitis', 'classes': [{'title': 'cellulitis', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'no cellulitis', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Clindamycin administered in ED', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of abscess', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of household contact with abscess', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Presence of ≥ 2 Abscesses', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Abscess size', 'classes': [{'categories': [{'measurements': [{'value': '6.25', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '12'}, {'value': '6.25', 'groupId': 'BG001', 'lowerLimit': '4', 'upperLimit': '12'}, {'value': '6.25', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Culture results', 'classes': [{'title': 'MRSA', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}]}, {'title': 'MSSA', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'No Growth', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-17', 'studyFirstSubmitDate': '2013-12-26', 'resultsFirstSubmitDate': '2014-09-08', 'studyFirstSubmitQcDate': '2013-12-27', 'lastUpdatePostDateStruct': {'date': '2015-10-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-08', 'studyFirstPostDateStruct': {'date': '2013-12-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Failures', 'timeFrame': 'up to 2 weeks after surgical drainage', 'description': 'Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.'}, {'measure': 'Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus', 'timeFrame': 'up to 2 weeks after surgical drainage', 'description': 'Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.'}, {'measure': 'Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus', 'timeFrame': 'up to 2 weeks after surgical drainage', 'description': 'Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.'}], 'secondaryOutcomes': [{'measure': 'Recurrent Skin Infections', 'timeFrame': '1 month after surgical drainage', 'description': 'Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.'}, {'measure': 'Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus', 'timeFrame': '1 month after surgical drainage', 'description': 'Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.'}, {'measure': 'Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus', 'timeFrame': '1 month after surgical drainage', 'description': 'Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Methicillin resistent Staphylococcus aureus', 'Staphylococcus aureus'], 'conditions': ['Skin Disease, Bacterial', 'Abscess']}, 'referencesModule': {'references': [{'pmid': '19409657', 'type': 'BACKGROUND', 'citation': 'Duong M, Markwell S, Peter J, Barenkamp S. Randomized, controlled trial of antibiotics in the management of community-acquired skin abscesses in the pediatric patient. Ann Emerg Med. 2010 May;55(5):401-7. doi: 10.1016/j.annemergmed.2009.03.014. Epub 2009 May 5.'}, {'pmid': '20346539', 'type': 'BACKGROUND', '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.'}, {'pmid': '26578074', 'type': 'DERIVED', 'citation': 'Holmes L, Ma C, Qiao H, Drabik C, Hurley C, Jones D, Judkiewicz S, Faden H. Trimethoprim-Sulfamethoxazole Therapy Reduces Failure and Recurrence in Methicillin-Resistant Staphylococcus aureus Skin Abscesses after Surgical Drainage. J Pediatr. 2016 Feb;169:128-34.e1. doi: 10.1016/j.jpeds.2015.10.044. Epub 2015 Nov 11.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine if there is a difference in treatment failures and recurrent skin infections when patients are given 3 or 10 days of antibiotics for uncomplicated skin abscesses after they have been surgically drained.', 'detailedDescription': 'Patients age 3 months to 17 years presenting to a pediatric Emergency Department (ED) with an uncomplicated skin abscess that required surgical drainage were randomized to receive 3 or 10 days of oral trimethoprim-sulfamethoxazole. Patients were evaluated 10 to 14 days later to assess for cure. Patients were contacted 1 month later to determine if they had developed another skin infection. Outcomes were also stratified by methicillin-resistent staphylococcus aureus (MRSA) and methicillin-sensitive staphylococcus aureus (MSSA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients presenting with a skin abscess that requires surgical drainage (induration ≥ 1 cm in diameter)\n* minimally invasive surgical technique with the insertion of a subcutaneous drain can be utilized on the patient\n\nExclusion Criteria:\n\n* patients requiring immediate hospitalization\n* patients who have received 2 or more doses of antibiotics in the previous 36 hours\n* patients with diabetes, sickle-cell disease, an immuno-compromising disease, an underlying medical condition predisposing the patient to frequent hospitalizations or medical visits, or indwelling catheters or percutaneous medical devices\n* patients with a concurrent, non-abscess infection\n* patients with an allergy to Trimethoprim-sulfamethoxazole'}, 'identificationModule': {'nctId': 'NCT02024867', 'briefTitle': 'Evaluation of 3 Versus 10 Days of Antibiotics in Skin Abscesses After Surgical Drainage', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Randomized Non-inferiority Trial of 3 Versus 10 Days of Trimethoprim-Sulfamethoxazole in Community-Associated Skin Abscesses After Surgical Drainage', 'orgStudyIdInfo': {'id': 'DB 2456'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '10 days of Trimethoprim-Sulfamethoxazole', 'description': 'Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day', 'interventionNames': ['Drug: Trimethoprim-Sulfamethoxazole']}, {'type': 'EXPERIMENTAL', 'label': '3 days of Trimethoprim-Sulfamethoxazole', 'description': 'Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day', 'interventionNames': ['Drug: Trimethoprim-Sulfamethoxazole']}], 'interventions': [{'name': 'Trimethoprim-Sulfamethoxazole', 'type': 'DRUG', 'otherNames': ['Septra', 'Bactrim'], 'description': '3 versus 10 days of drug', 'armGroupLabels': ['10 days of Trimethoprim-Sulfamethoxazole', '3 days of Trimethoprim-Sulfamethoxazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14222', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': "Women & Children's Hospital of Buffalo", 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Lucy C Holmes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University at Buffalo'}, {'name': 'Howard Faden, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University at Buffalo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lucy Holmes, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'New York State Department of Health', 'class': 'OTHER_GOV'}, {'name': "Women & Children's Hospital of Buffalo", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor of Pediatrics', 'investigatorFullName': 'Lucy Holmes, MD', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}