Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.
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|ClinicalTrials.gov Identifier: NCT00555061|
Recruitment Status : Completed
First Posted : November 7, 2007
Results First Posted : April 30, 2010
Last Update Posted : December 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Skin Infections, Bacterial||Drug: Retapamulin Ointment, 1%||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Non-Comparative Study to Assess the Pharmacokinetics, Safety and Efficacy of Topical Retapamulin (SB-275833) Ointment, 1%, Twice Daily for Five Days in the Treatment of Uncomplicated Skin and Skin Structure Infections in Pediatric Subjects Aged 2 to 24 Months|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
Experimental: Arm 1
Single Arm Retapamulin 1% Ointment
Drug: Retapamulin Ointment, 1%
- Number of Participants With Measurable Plasma Concentrations, by Age Group [ Time Frame: Days 3 to 4; 4 to 8 hours post-dose of the first dose of the day ]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.
- Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age [ Time Frame: Follow-up, Days 12 to 16 ]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.
- Bacteriological Success Rate at Follow-up, by Baseline Pathogen [ Time Frame: Follow-up, Days 12 to 16 ]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.
- Number of Participants by Age With Therapeutic Response of Success [ Time Frame: Follow-up, Days 12 to 16 ]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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555061
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|