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NCT00852540 · ClinicalTrials.gov registry record · Phase 3
Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA
A Phase 3 study of Skin Infections, Bacterial, sponsored by Stiefel, a GSK Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 410
- Enrollment target
- 20
- Study locations
NCT00852540: Completed Phase 3 study of Skin Infections, Bacterial, sponsored by Stiefel, a GSK Company.
NCT00852540 is a Phase 3 study of Skin Infections, Bacterial that has completed, run by Stiefel, a GSK Company. The registered enrollment target is 410 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00852540, a Phase 3 study of Skin Infections, Bacterial, has completed, sponsored by Stiefel, a GSK Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 410 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to provide further evidence of the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with SITL or impetigo due to MRSA. Subjects aged 2 months and older will be treated with either topical retapamulin for 5 days or oral linezolid for 10 days. The primary endpoint is the clinical response at follow-up (7-9 days after the end of therapy) in subjects who have a MRSA infection at baseline. The primary population is the per-protocol MRSA population. It is anticipated that approximately 500 subjects may be enrolled in order to obtain approximately 105 subjects who have a baseline MRSA infection.
Primary Outcome
Follow-up is defined as 7-9 days post-therapy: Day 12-14 for retapamulin; Day 17-19 for linezolid. Clinical success at follow-up was defined as the resolution of clinically meaningful signs and symptoms of infection recorded at baseline, including a pus/exudate skin infection rating scale (SIRS) score of "0." The SIRS is used by the investigator to evaluate infected lesions. Scores on the SIRS range from 0 (absent) to 6 (severe).
Conditions Studied
Interventions
- DRUG Linezolid
- DRUG Retpamulin Ointment, 1%
Study Locations (20)
Florida
- GSK Investigational Site - Atlantis
- GSK Investigational Site - Bay Pines
- GSK Investigational Site - Fort Lauderdale
- GSK Investigational Site - Fort Lauderdale
- GSK Investigational Site - Miami
- GSK Investigational Site - Pensacola
- GSK Investigational Site - St. Petersburg
California
- GSK Investigational Site - Bakerfield
- GSK Investigational Site - Bell Gardens
- GSK Investigational Site - Huntington Beach
- GSK Investigational Site - Long Beach
- GSK Investigational Site - Roseville
- GSK Investigational Site - Sacramento
Arkansas
- GSK Investigational Site - Bentonville
- GSK Investigational Site - Jonesboro
- GSK Investigational Site - Paragould
Alabama
- GSK Investigational Site - Anniston
- GSK Investigational Site - Birmingham
Colorado
- GSK Investigational Site - Colorado Springs
District of Columbia
- GSK Investigational Site - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 410 participants |
| Start Date | 2009-04 |
| Est. Completion | 2010-09 |
| Phase | Phase 3 |
What the finished NCT00852540 record still lists
NCT00852540 is an interventional study that assigns participants to a tested intervention. The registered 410 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Skin Infections, Bacterial appearing as the primary indexed condition, and to 2 interventions - of which Linezolid is the first listed.
NCT00852540 names 20 study sites across 6 states, led by Florida, California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT00852540 about?
NCT00852540 is a clinical study titled "Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA". The purpose of this study is to provide further evidence of the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with SITL or impetigo due to MRSA. Subjects aged 2 months and older will be treated with either topical retapamulin for 5 days or oral linezolid for 10 da...
What is the current status of trial NCT00852540?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 410 participants. The study started on 2009-04. Estimated completion is 2010-09.
What conditions does trial NCT00852540 study?
This clinical trial studies the following conditions: Skin Infections, Bacterial.
What interventions are being tested in trial NCT00852540?
The interventions under investigation include: Linezolid (DRUG), Retpamulin Ointment, 1% (DRUG).
Who is sponsoring clinical trial NCT00852540?
This trial is sponsored by Stiefel, a GSK Company, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00852540 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Skin Infections, Bacterial
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00852540's enrollment target sits among peer trials
410 909th of 2000 higher than 1,090 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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