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NCT01820455 · ClinicalTrials.gov registry record · NA
MRSA in a Trauma Population: Does Decolonization Prevent Infection?
A NA study, sponsored by University of Tennessee.
- Completed
- Registry status
- NA
- Development phase
- 55
- Enrollment target
NCT01820455: Completed NA study, sponsored by University of Tennessee.
NCT01820455 is a NA study that has completed, run by University of Tennessee. The registered enrollment target is 55 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01820455, a NA study, has completed, sponsored by University of Tennessee.
- COMPLETED
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
Study Summary
All trauma patients admitted to certain Intensive Care Units (ICU) will have Methicillin-resistant Staphylococcus aureus (MRSA) nasal swabs performed to determine MRSA colonization status. Only those patients who are determined to be colonized with MRSA at admission will be included in the study. All patients must be age 18 and older, admitted directly to the ICU from either the Emergency Department or the operating room with trauma-related injuries, and must not have active or recent known history of MRSA infections. Once patients have been determined to be colonized with MRSA, they will be randomized to receive "decolonization" treatment or placebo. "Decolonization" treatment will include Chlorhexidine baths and Mupirocin ointment to both nares for 5 days and placebo will entail "routine" soap baths and Lubricating Jelly. Both groups will be kept on standard contact precautions throughout the course of the study. Repeat nasal swabs will be performed at the completion of the treatment regimen to determine the efficacy. Patients will be screened for invasive MRSA infections as dictated by their clinical course. The primary outcome measure will be invasive MRSA infection rate (pneumonia, urinary tract infection, bacteremia and soft tissue infection). Secondary endpoints include hospital lengths of stay, ICU lengths of stay, mechanical ventilatory support requirements, colonization status at the end of treatment, and death rates. As determined by our power analysis, we aim to enroll 75 patients in each arm over the course of 12-24 months.
Primary Outcome
Measurement of decolonization of MRSA as determined by polymerase chain reaction (PCR) from the nares of critically ill trauma population following treatment.
Interventions
- DRUG Chlorhexidine, Mupirocin
- DRUG Soap baths, Lubricating Jelly
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-03 |
| Phase | NA |
What the finished NCT01820455 record still lists
NCT01820455 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Chlorhexidine, Mupirocin is the first listed.
NCT01820455 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01820455 about?
NCT01820455 is a clinical study titled "MRSA in a Trauma Population: Does Decolonization Prevent Infection?". All trauma patients admitted to certain Intensive Care Units (ICU) will have Methicillin-resistant Staphylococcus aureus (MRSA) nasal swabs performed to determine MRSA colonization status. Only those patients who are determined to be colonized with MRSA at admission will be included in the study. Al...
What is the current status of trial NCT01820455?
This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2012-01. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01820455?
The interventions under investigation include: Chlorhexidine, Mupirocin (DRUG), Soap baths, Lubricating Jelly (DRUG).
Who is sponsoring clinical trial NCT01820455?
This trial is sponsored by University of Tennessee, which has 96 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01820455's enrollment target sits among peer trials
55 1264th of 2000 higher than 733 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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