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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 is a Phase 4 study that has completed, run by University of California, Irvine. The registered enrollment target is 53 participants.
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.
Interventions
- DRUG Placebo
- DRUG Retapamulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2012-07 |
| Est. Completion | 2017-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01461668
The ClinicalTrials.gov registry entry for NCT01461668 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01461668 reports 0 study locations.
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.
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