Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-02-11 @ 6:57 AM
Study NCT ID:
NCT00555061
Status:
COMPLETED
Last Update Posted:
2016-12-28
First Post:
2007-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002481', 'term': 'Cellulitis'}, {'id': 'D013398', 'term': 'Sudden Infant Death'}, {'id': 'D007169', 'term': 'Impetigo'}, {'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D066088', 'term': 'Infant Death'}, {'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': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Retapamulin Ointment, 1%', 'description': 'Retapamulin ointment, 1%, administered twice daily for 5 consecutive days', 'otherNumAffected': 11, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atopic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skin fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypochromic anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Measurable Plasma Concentrations, by Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment, 1%', 'description': 'Retapamulin ointment, 1%, administered twice daily for 5 consecutive days'}], 'classes': [{'title': 'All ages', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': '≥2 months to ≤6 months', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': '>6 months to ≤12 months', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': '>12 months to ≤24 months', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 3 to 4; 4 to 8 hours post-dose of the first dose of the day', 'description': 'Pharmacokinetic (PK) samples were collected randomly in the window of 4 to 8 hours post-dose (except one at 3 hours and one at 11 hours post-dose) after the first daily dose of treatment on Day 3 or Day 4. The lower limit of quantification (LLQ) for retapamulin was 0.5 ng/mL.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Population: all participants who received at least one dose of study medication and who had PK samples taken. Seven participants did not have PK samples collected.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment, 1%', 'description': 'Retapamulin ointment, 1%, administered twice daily for 5 consecutive days'}], 'classes': [{'title': 'Impetigo, ≥2 months to ≤6 months, n=11', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Impetigo, >6 months to ≤12 months, n=18', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Impetigo, >12 months to ≤24 months, n=18', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'SID, ≥2 months to ≤6 months, n=17', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'SID, >6 months to ≤12 months, n=9', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'SID, >12 months to ≤24 months, n=4', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'SITL, ≥2 months to ≤6 months, n=1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'SITL, >6 months to ≤12 months, n=2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'SITL, >12 months to ≤24 months, n=6', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up, Days 12 to 16', 'description': 'SID = Secondarily Infected Dermatoses; SITL = Secondarily Infected Traumatic Lesions. Clinical Success is the number of participants with resolution of signs/symptoms of infection or improvement such that no additional antibiotic therapy was needed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Clinical (ITTC) Population: all participants who received at least one dose of study medication; the number of participants who were clinical successes out of the total number in each respective category is shown'}, {'type': 'SECONDARY', 'title': 'Bacteriological Success Rate at Follow-up, by Baseline Pathogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment, 1%', 'description': 'Retapamulin ointment, 1%, administered twice daily for 5 consecutive days'}], 'classes': [{'title': 'All pathogens, n=93', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}, {'title': 'Staphylococcus aureus (SA), n=44', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Methicillin-resistant SA, n=3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Methicillin-susceptible SA, n=41', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Mupirocin-susceptible SA, n=44', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Fuscidic acid-resistant SA, n=2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Fuscidic acid-susceptible SA, n=42', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Streptococcus pyogenes, n=9', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Other Gram (+) pathogens, n=11', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Gram (-) pathogens, n=29', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up, Days 12 to 16', 'description': 'Bacteriological success is defined as: (1) Bacteriological Eradication, elimination of the baseline pathogen via culture results; (2) Presumed Bacteriological Eradication, clinical success plus no culturable material from the wound; or (3) Colonization, new pathogen identified at Follow-up in a non-symptomatic participant who does not require additional antibiotic therapy. The number of pathogens eradicated out of the number isolated (shown as "n" in the category title) for each respective category is shown.', 'unitOfMeasure': 'number of pathogens eradicated', 'reportingStatus': 'POSTED', 'populationDescription': 'ITTB (Intent-to-Treat Bacteriological) Population: participants who had at least one dose of study medication and a clinical diagnosis of infection plus a pathogen isolated at Baseline. Participants with more than one pathogen may be represented in the table more than once.'}, {'type': 'SECONDARY', 'title': 'Number of Participants by Age With Therapeutic Response of Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Retapamulin Ointment, 1%', 'description': 'Retapamulin ointment, 1%, administered twice daily for 5 consecutive days'}], 'classes': [{'title': 'All ages', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': '>2 months to <=6 months, n=21', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': '>6 months to <=12 months, n=20', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': '>12 months to <=24 months, n=20', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up, Days 12 to 16', 'description': 'Therapeutic response is a measure of the overall efficacy response; a response of "therapeutic success" was based on both clinical success and bacteriological success in a given participant.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITTB and ITTC Populations. The number analyzed is the number of participants who were clinical successes both in the ITTC Population and the ITTB Population; the number of participants who were therapeutic successes out of the total number in each respective category is shown.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Retapamulin Ointment, 1%', 'description': 'Retapamulin ointment, 1%, administered twice daily for 5 consecutive days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One participant did not receive study medication and was not included in the analysis population.', 'groupId': 'FG000', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Participant enrolled, but never treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Retapamulin Ointment, 1%', 'description': 'Retapamulin ointment, 1%, administered twice daily for 5 consecutive days'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'spread': '6.89', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'One participant was enrolled, but was withdrawn prior to assessments and did not receive study medication; therefore, this participant was not included in the study population.', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'One participant was enrolled, but was withdrawn prior to assessments and did not receive study medication; therefore, this participant was not included in the study population.', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American/African Heritage', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}, {'title': 'White/Caucasian', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Central/South Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'East Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'One participant was enrolled, but was withdrawn prior to assessments and did not receive study medication; therefore, this participant was not included in the study population.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-04', 'studyFirstSubmitDate': '2007-11-06', 'resultsFirstSubmitDate': '2009-08-10', 'studyFirstSubmitQcDate': '2007-11-06', 'lastUpdatePostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-04-08', 'studyFirstPostDateStruct': {'date': '2007-11-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Measurable Plasma Concentrations, by Age Group', 'timeFrame': 'Days 3 to 4; 4 to 8 hours post-dose of the first dose of the day', 'description': 'Pharmacokinetic (PK) samples were collected randomly in the window of 4 to 8 hours post-dose (except one at 3 hours and one at 11 hours post-dose) after the first daily dose of treatment on Day 3 or Day 4. The lower limit of quantification (LLQ) for retapamulin was 0.5 ng/mL.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age', 'timeFrame': 'Follow-up, Days 12 to 16', 'description': 'SID = Secondarily Infected Dermatoses; SITL = Secondarily Infected Traumatic Lesions. Clinical Success is the number of participants with resolution of signs/symptoms of infection or improvement such that no additional antibiotic therapy was needed.'}, {'measure': 'Bacteriological Success Rate at Follow-up, by Baseline Pathogen', 'timeFrame': 'Follow-up, Days 12 to 16', 'description': 'Bacteriological success is defined as: (1) Bacteriological Eradication, elimination of the baseline pathogen via culture results; (2) Presumed Bacteriological Eradication, clinical success plus no culturable material from the wound; or (3) Colonization, new pathogen identified at Follow-up in a non-symptomatic participant who does not require additional antibiotic therapy. The number of pathogens eradicated out of the number isolated (shown as "n" in the category title) for each respective category is shown.'}, {'measure': 'Number of Participants by Age With Therapeutic Response of Success', 'timeFrame': 'Follow-up, Days 12 to 16', 'description': 'Therapeutic response is a measure of the overall efficacy response; a response of "therapeutic success" was based on both clinical success and bacteriological success in a given participant.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SID', 'impetigo', 'pharmacokinetics', 'Retapamulin ointment, 1%', 'Skin abnormalities', 'Dermatoses', 'pediatric', 'infection', 'SITL'], 'conditions': ['Skin Infections, Bacterial']}, 'referencesModule': {'availIpds': [{'id': 'TOC106489', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'TOC106489', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'TOC106489', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'TOC106489', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'TOC106489', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'TOC106489', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'TOC106489', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'A study to evaluate the pharmacokinetics of Retapamulin Ointment, 1%, in pediatric subjects (2-24 months) with secondarily-infected traumatic lesions, secondarily-infected dermatoses, or impetigo (bullous and non-bullous).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Subject Age: The subject is ≥2 months to ≤24 months of age at study entry\n* Subject Diagnosis: The subject has a diagnosis of secondarily-infected traumatic lesion (SITL), secondarily-infected dermatoses (SID), or primary impetigo (bullous or non-bullous) that is suitable for treatment with topical antibacterial therapy:\n\nThe subject has a small laceration, sutured wound or abrasion, which has a secondary bacterial infection. The infected portion of the laceration or sutured wound should not exceed 10cm in length with surrounding erythema not extending more than 2cm from the edge of the wound. Abrasions should not exceed 2% of the total body surface area with surrounding erythema not extending more than 2cm from the edge of the abrasion.\n\nThe subject has a diagnosis of inflammatory skin disease (i.e., dermatosis), such as atopic dermatitis or contact dermatitis, which has a secondary bacterial infection. The infected portion of the lesion(s) should not exceed 2% of the total body surface area.\n\nImpetigo: The subject has a lesion or group of £10 discrete localized lesions on otherwise healthy skin, characterized by red spots or blisters without crusts which later progress to lesions which ooze and form yellow or honey-colored crusts surrounded by an erythematous margin.\n\n* Subject SIRS Score: The subject has a total SIRS score of at least 8 (Appendix 1 Skin Infection Rating Scale)\n* Protocol Compliance: The parent/legal guardian is willing to comply with the protocol\n* Informed Consent: The parent/legal guardian has given written informed, dated consent for the subject to participate in the study\n* French Subjects: In France, a subject will be eligible for inclusion in this study if either affiliated to or a beneficiary of a social security category\n\nExclusion criteria:\n\n* The subject has demonstrated a previous hypersensitivity reaction to pleuromutilin or any component of the ointment (refer to the Investigator Brochure for composition of Retapamulin ointment, 1%)\n* The subject was considered to be premature at birth (\\<37 weeks gestation)\n* The subject has a secondarily-infected animal/human bite, or a puncture wound\n* The subject has an abscess\n* The subject has a chronic ulcerative lesion that is unlikely to have Staphylococcus aureus or Streptococcus pyogenes as the causative agent\n* The subject has systemic signs and symptoms of infection (such as fever; defined as a temperature equivalent to a rectal temperature greater than 101°F or 38.3°C)\n* The subject has a bacterial skin infection which, due to area, depth or severity, in the opinion of the investigator, cannot be appropriately treated by a topical antibiotic\n* The subject has more than one type of infected lesion as defined in the protocol\n* The subject requires surgical intervention for treatment of the infection prior to enrollment in the study, or is likely to require such intervention during the course of the study\n* The subject has applied any topical therapeutic agent (including glucocorticoid steroids, antibacterials or antifungals) directly to the infected wound/lesion, within 24 hours prior to study entry\n* The subject has received one or more days of treatment with a systemic antibacterial within 72 hours of study entry\n* The subject is receiving systemic corticosteroids at a dose of \\>0.125mg/kg per day of prednisone (or the equivalent)\n* The subject has a known, pre-existing, serious underlying disease that could be imminently life-threatening\n* The subject has participated in any study using an investigational drug during the previous 30 days prior to entering the study\n* The subject has been previously enrolled in this study or in any other study involving Retapamulin'}, 'identificationModule': {'nctId': 'NCT00555061', 'briefTitle': 'Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.', 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