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NCT01461668 · ClinicalTrials.gov registry record · Phase 4
Retapamulin for Reducing MRSA Nasal Carriage
A Phase 4 study, sponsored by University of California, Irvine.
- Completed
- Registry status
- Phase 4
- Development phase
- 53
- Enrollment target
NCT01461668: Completed Phase 4 study, sponsored by University of California, Irvine.
NCT01461668 is a Phase 4 study that has completed, run by University of California, Irvine. The registered enrollment target is 53 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01461668, a Phase 4 study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 53 participants
- Enrollment target
Study Summary
The investigators will conduct a randomized placebo-controlled double-blinded study of nasal decolonization with retapamulin vs. placebo for the eradication of MRSA nasal carriage among adult carriers with low-level (MIC 8-256) and high-level mupirocin resistant (MIC \>256) strains. Objectives: 1. To determine the percent of intervention vs. control patients with successful MRSA nasal decolonization as determined by bilateral nares swabs following a 5-day twice-a-day regimen of retapamulin. 2. To determine the time to decolonization based upon interim and final bilateral nares swabs. 3. To determine the acceptability of retapamulin by surveying participants about their experience and adverse events experienced during this study. The duration of participant follow-up is expected to last up to 7 weeks. This study will evaluate the safety and effectiveness of Altabax (retapamulin) during decolonization of MRSA carriers with mupirocin-resistant strains, stratified by low-level and high-level resistance to mupirocin. Mupirocin resistance is increasingly common and there is no approved substitute topical agent for decolonization of the MRSA nasal reservoir.
Primary Outcome
Proportion of participants with MRSA clearance at the end of the follow up period
Interventions
- DRUG Placebo
- DRUG Retapamulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2012-07 |
| Est. Completion | 2017-12 |
| Phase | Phase 4 |
What the finished NCT01461668 record still lists
NCT01461668 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01461668 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01461668 about?
NCT01461668 is a clinical study titled "Retapamulin for Reducing MRSA Nasal Carriage". The investigators will conduct a randomized placebo-controlled double-blinded study of nasal decolonization with retapamulin vs. placebo for the eradication of MRSA nasal carriage among adult carriers with low-level (MIC 8-256) and high-level mupirocin resistant (MIC \>256) strains. Objectives: 1....
What is the current status of trial NCT01461668?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 53 participants. The study started on 2012-07. Estimated completion is 2017-12.
What interventions are being tested in trial NCT01461668?
The interventions under investigation include: Placebo (DRUG), Retapamulin (DRUG).
Who is sponsoring clinical trial NCT01461668?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01461668's enrollment target sits among peer trials
53 1229th of 2000 higher than 768 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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