Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.

Phase 4

Completed

• Conditions: Skin Infections, Bacterial
• Interventions: Drug: Retapamulin Ointment, 1%

• Registration Number: NCT00555061
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-11-06
• Study First Submitted QC: 2007-11-06
• Study First Posted: 2007-11-07
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2009-08-10
• Results First Submitted QC: 2010-04-08
• Results First Posted: 2010-04-30
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-04
• Last Update Posted: 2016-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Retapamulin Ointment, 1%	Single Arm Retapamulin 1% Ointment

Primary Outcome Measures

Name	Time	Method
Number of Participants With Measurable Plasma Concentrations, by Age Group	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age	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.
Number of Participants by Age With Therapeutic Response of Success	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.
Bacteriological Success Rate at Follow-up, by Baseline Pathogen	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇳 Taipei, Taiwan