Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-02 @ 11:50 AM
Study NCT ID:
NCT01126268
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2010-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007169', 'term': 'Impetigo'}, {'id': 'D005499', 'term': 'Folliculitis'}, {'id': 'D004485', 'term': 'Eczema'}, {'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D013207', 'term': 'Staphylococcal Skin Infections'}, {'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C508887', 'term': 'retapamulin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Adelaide.A.Hebert@uth.tmc.edu', 'phone': '(713) 500-8339', 'title': 'Dr. Adelaide A Hebert', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '5 days', 'eventGroups': [{'id': 'EG000', 'title': 'Retapamulin Ointment 1%', 'description': 'Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days', 'otherNumAtRisk': 38, 'otherNumAffected': 4, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Burning at Retapamulin (Altabax) application site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash at site other than the Retapamulin (Altabax) application site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were Determined to be a Clinical Success at the Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment 1%', 'description': 'Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 days after treatment', 'description': 'Clinical success is defined as no further signs or symptoms of infection present, including erythema, purulence, crusting, edema, warmth and pain.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants whose wound cultures were positive for MRSA'}, {'type': 'SECONDARY', 'title': 'Clinical Response at Follow up as Assessed by a Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment 1%', 'description': 'Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days'}], 'classes': [{'title': '1. Clinical success', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': '2. Clinical improvement', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': '3. No change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '4. Clinical failure', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '5. Unable to determine', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 days after treatment', 'description': 'Clinical response was based on clinical evaluation by the investigator at the follow-up visit using a predefined scale with the following categories: (1) clinical success, (2) clinical improvement, (3) no change, (4) clinical failure, and (5) unable to determine. Patients who were designated as clinical success as defined in number 1 above were considered a true "clinical success" while all others were considered a "clinical failure." Patients were classified with an outcome of "unable to determine" if they missed their follow-up visit or refused clinical examination.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing'}, {'type': 'SECONDARY', 'title': 'Microbiologic Response at Follow up as Assessed by a Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment 1%', 'description': 'Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days'}], 'classes': [{'title': '1. Microbiological eradication', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '2. Presumed microbiological eradication', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': '3. Presumed microbiological improvement', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': '4. Microbiological persistence', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '5. Presumed microbiological persistence', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '6. Unable to determine', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '7. New pathogen', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '8. Colonization', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 days after treatment', 'description': 'Microbiological response was determined by the investigator at the follow-up visit using the following microbiological outcomes: (1) microbological eradication, (2) presumed microbiological eradication, (3) presumed microbiological improvement, (4) microbiological persistence, (5) presumed microbiological persistence, (6) unable to determine, (7) new pathogen, and (8) colonization. Patients who were designated microbiological eradication, presumed microbiological eradication, presumed microbiological improvement, or colonization as defined in numbers 1, 2, 3, and 8 above were considered a "microbiological success" while all others were considered "microbiological failure."', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Were a Therapeutic Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment 1%', 'description': 'Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 days after treatment', 'description': 'Therapeutic response was determined from the clinical response and the microbiological response. Patients who qualified as both a "clinical success" and a "microbiological success" were deemed a "therapeutic success," and all others were deemed "therapeutic failures."', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing'}, {'type': 'SECONDARY', 'title': 'Erythema (Sign and Symptom of Infection) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment 1%', 'description': 'Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days'}], 'classes': [{'title': 'Absent', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Minimal', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing'}, {'type': 'SECONDARY', 'title': 'Erythema (Sign and Symptom of Infection) at Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment 1%', 'description': 'Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days'}], 'classes': [{'title': 'Absent', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Minimal', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 days after treatment', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing'}, {'type': 'SECONDARY', 'title': 'Purulence (Sign and Symptom of Infection) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment 1%', 'description': 'Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days'}], 'classes': [{'title': 'Absent', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Minimal', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing'}, {'type': 'SECONDARY', 'title': 'Purulence (Sign and Symptom of Infection) at Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment 1%', 'description': 'Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days'}], 'classes': [{'title': 'Absent', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Minimal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 days after treatment', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing'}, {'type': 'SECONDARY', 'title': 'Crusting (Sign and Symptom of Infection) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment 1%', 'description': 'Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days'}], 'classes': [{'title': 'Absent', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Minimal', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing'}, {'type': 'SECONDARY', 'title': 'Crusting (Sign and Symptom of Infection) at Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment 1%', 'description': 'Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days'}], 'classes': [{'title': 'Absent', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Minimal', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 days after treatment', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing'}, {'type': 'SECONDARY', 'title': 'Tissue Edema (Sign and Symptom of Infection) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment 1%', 'description': 'Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days'}], 'classes': [{'title': 'Absent', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Minimal', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing'}, {'type': 'SECONDARY', 'title': 'Tissue Edema (Sign and Symptom of Infection) at Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment 1%', 'description': 'Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days'}], 'classes': [{'title': 'Absent', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Minimal', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 days after treatment', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing'}, {'type': 'SECONDARY', 'title': 'Tissue Warmth (Sign and Symptom of Infection) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment 1%', 'description': 'Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days'}], 'classes': [{'title': 'Absent', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Minimal', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing'}, {'type': 'SECONDARY', 'title': 'Tissue Warmth (Sign and Symptom of Infection) at Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment 1%', 'description': 'Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days'}], 'classes': [{'title': 'Absent', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Minimal', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 days after treatment', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing'}, {'type': 'SECONDARY', 'title': 'Pain (Sign and Symptom of Infection) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment 1%', 'description': 'Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days'}], 'classes': [{'title': 'Absent', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Minimal', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing'}, {'type': 'SECONDARY', 'title': 'Pain (Sign and Symptom of Infection) at Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment 1%', 'description': 'Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days'}], 'classes': [{'title': 'Absent', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Minimal', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 to 8 days after treatment', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing'}, {'type': 'SECONDARY', 'title': 'Wound Size at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment 1%', 'description': 'Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days'}], 'classes': [{'categories': [{'measurements': [{'value': '14.43', 'spread': '25.38', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'Wound size area was determined by measuring the greatest length of the wound in two perpendicular dimensions with a standard metric ruler. The two measurements were multiplied together to provide an estimate of the overall wound size. Surrounding erythema was not included in the measurement.', 'unitOfMeasure': 'cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing'}, {'type': 'SECONDARY', 'title': 'Wound Size at Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment 1%', 'description': 'Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days'}], 'classes': [{'categories': [{'measurements': [{'value': '4.31', 'spread': '17.71', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 to 8 days after treatment', 'description': 'Wound size area was determined by measuring the greatest length of the wound in two perpendicular dimensions with a standard metric ruler. The two measurements were multiplied together to provide an estimate of the overall wound size. Surrounding erythema was not included in the measurement.', 'unitOfMeasure': 'cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Any Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment 1%', 'description': 'Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline to 6 to 8 days after treatment', 'description': 'AEs included burning at application site, upper respiratory infection, furuncle, cough, and a rash at a site other than the application site. See the Adverse Events section for more detailed information.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of Retapamulin (Altabax)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Retapamulin Ointment 1% Group', 'description': 'Subjects with clinically diagnosed with impetigo, folliculitis, or minor soft tissue infection suitable for treatment with a topical antibiotic were screened, and if qualified, they received topical retapamulin ointment 1% twice daily for 5 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Retapamulin Ointment 1%', 'description': 'Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '18.5', 'spread': '25.66', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-20', 'studyFirstSubmitDate': '2010-04-19', 'resultsFirstSubmitDate': '2015-12-14', 'studyFirstSubmitQcDate': '2010-05-18', 'lastUpdatePostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-20', 'studyFirstPostDateStruct': {'date': '2010-05-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were Determined to be a Clinical Success at the Follow-up Visit', 'timeFrame': '6 to 8 days after treatment', 'description': 'Clinical success is defined as no further signs or symptoms of infection present, including erythema, purulence, crusting, edema, warmth and pain.'}], 'secondaryOutcomes': [{'measure': 'Clinical Response at Follow up as Assessed by a Rating Scale', 'timeFrame': '6 to 8 days after treatment', 'description': 'Clinical response was based on clinical evaluation by the investigator at the follow-up visit using a predefined scale with the following categories: (1) clinical success, (2) clinical improvement, (3) no change, (4) clinical failure, and (5) unable to determine. Patients who were designated as clinical success as defined in number 1 above were considered a true "clinical success" while all others were considered a "clinical failure." Patients were classified with an outcome of "unable to determine" if they missed their follow-up visit or refused clinical examination.'}, {'measure': 'Microbiologic Response at Follow up as Assessed by a Rating Scale', 'timeFrame': '6 to 8 days after treatment', 'description': 'Microbiological response was determined by the investigator at the follow-up visit using the following microbiological outcomes: (1) microbological eradication, (2) presumed microbiological eradication, (3) presumed microbiological improvement, (4) microbiological persistence, (5) presumed microbiological persistence, (6) unable to determine, (7) new pathogen, and (8) colonization. Patients who were designated microbiological eradication, presumed microbiological eradication, presumed microbiological improvement, or colonization as defined in numbers 1, 2, 3, and 8 above were considered a "microbiological success" while all others were considered "microbiological failure."'}, {'measure': 'Number of Participants Who Were a Therapeutic Success', 'timeFrame': '6 to 8 days after treatment', 'description': 'Therapeutic response was determined from the clinical response and the microbiological response. Patients who qualified as both a "clinical success" and a "microbiological success" were deemed a "therapeutic success," and all others were deemed "therapeutic failures."'}, {'measure': 'Erythema (Sign and Symptom of Infection) at Baseline', 'timeFrame': 'baseline', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.'}, {'measure': 'Erythema (Sign and Symptom of Infection) at Follow up', 'timeFrame': '6 to 8 days after treatment', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.'}, {'measure': 'Purulence (Sign and Symptom of Infection) at Baseline', 'timeFrame': 'baseline', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.'}, {'measure': 'Purulence (Sign and Symptom of Infection) at Follow up', 'timeFrame': '6 to 8 days after treatment', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.'}, {'measure': 'Crusting (Sign and Symptom of Infection) at Baseline', 'timeFrame': 'baseline', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.'}, {'measure': 'Crusting (Sign and Symptom of Infection) at Follow up', 'timeFrame': '6 to 8 days after treatment', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.'}, {'measure': 'Tissue Edema (Sign and Symptom of Infection) at Baseline', 'timeFrame': 'baseline', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.'}, {'measure': 'Tissue Edema (Sign and Symptom of Infection) at Follow up', 'timeFrame': '6 to 8 days after treatment', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.'}, {'measure': 'Tissue Warmth (Sign and Symptom of Infection) at Baseline', 'timeFrame': 'baseline', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.'}, {'measure': 'Tissue Warmth (Sign and Symptom of Infection) at Follow up', 'timeFrame': '6 to 8 days after treatment', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.'}, {'measure': 'Pain (Sign and Symptom of Infection) at Baseline', 'timeFrame': 'baseline', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.'}, {'measure': 'Pain (Sign and Symptom of Infection) at Follow up', 'timeFrame': '6 to 8 days after treatment', 'description': 'Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.'}, {'measure': 'Wound Size at Baseline', 'timeFrame': 'baseline', 'description': 'Wound size area was determined by measuring the greatest length of the wound in two perpendicular dimensions with a standard metric ruler. The two measurements were multiplied together to provide an estimate of the overall wound size. Surrounding erythema was not included in the measurement.'}, {'measure': 'Wound Size at Follow up', 'timeFrame': '6 to 8 days after treatment', 'description': 'Wound size area was determined by measuring the greatest length of the wound in two perpendicular dimensions with a standard metric ruler. The two measurements were multiplied together to provide an estimate of the overall wound size. Surrounding erythema was not included in the measurement.'}, {'measure': 'Number of Participants Reporting Any Adverse Event (AE)', 'timeFrame': 'baseline to 6 to 8 days after treatment', 'description': 'AEs included burning at application site, upper respiratory infection, furuncle, cough, and a rash at a site other than the application site. See the Adverse Events section for more detailed information.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Eczema', 'Atopic dermatitis', 'Infection', 'Impetigo', 'Folliculitis'], 'conditions': ['Impetigo', 'Folliculitis', 'Secondarily Infected Eczema', 'Minor Soft Tissue Infections']}, 'referencesModule': {'references': [{'pmid': '28491950', 'type': 'RESULT', 'citation': 'Bohaty BR, Choi S, Cai C, Hebert AA. Clinical and bacteriological efficacy of twice daily topical retapamulin ointment 1% in the management of impetigo and other uncomplicated superficial skin infections. Int J Womens Dermatol. 2015 Mar 2;1(1):13-20. doi: 10.1016/j.ijwd.2014.12.002. eCollection 2015 Feb.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to document the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with bacterial infections, including impetigo, folliculitis, and minor soft tissue infections including secondarily infected eczema presumed to be caused by methicillin resistant Staph aureus. Male and female patients ages 9 months to 98 years will be recruited from a university based dermatology clinic. Upon enrollment, wound cultures will be collected, and then subjects will apply topical retapamulin twice daily for five days. The primary endpoint will be resolution of methicillin-resistant Staphylococcus aureus (MRSA) infection based on clinical presentation and physical exam, as well as bacteriological efficacy based on culture results. It is anticipated that approximately 75 patients will be enrolled, with expectation that approximately 50 of these patients will have MRSA infections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '98 Years', 'minimumAge': '9 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients from 9 months of age up to 98 years of age.\n* Clinical diagnosis of impetigo, folliculitis, or minor soft tissue infection including secondarily infected eczema presumed to be caused by Staphylococcus aureus.\n* The patient, and if applicable the parent or guardian, is able to give informed consent\n* Females of child bearing potential have a negative urine pregnancy test.\n* Patient, and if applicable parent or guardian, are willing to and capable of complying with the study protocol.\n\nExclusion Criteria:\n\n* Subject who has used a topical antibacterial medication to the area being treated within the last 48 hours.\n* Subject who has been enrolled in a clinical trial within the last 30 days.\n* Subject with signs of systemic infection (such as fever), or with evidence of abscess or cellulitis at the site to be treated.\n* Subject has a bacterial skin infection which would not be appropriately treated by a topical antibiotic in the opinion of the investigator\n* Subjects who have taken oral antibiotics within the last 7 days.\n* Subjects with known sensitivity to the study medication.\n* The subject is pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT01126268', 'briefTitle': 'Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection', 'orgStudyIdInfo': {'id': 'HSC-MS-09-0650'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Retapamulin ointment 1%', 'interventionNames': ['Drug: Retapamulin (Altabax)']}], 'interventions': [{'name': 'Retapamulin (Altabax)', 'type': 'DRUG', 'otherNames': ['Altabax'], 'description': 'Retapamulin ointment, applied topically twice daily for five days', 'armGroupLabels': ['Retapamulin ointment 1%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Medical Center Building', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Adelaide A Hebert, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Health Science Center at Houston Department of Dermatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Dermatology and Pediatrics', 'investigatorFullName': 'Adelaide Hebert', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}