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MRSA in a Trauma Population: Does Decolonization Prevent Infection?

NCT ID: NCT01820455

Last Updated: 2014-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Partway through the enrollment period, it was determined that in the best interests of the patients, the protocol would be altered to eliminate the randomization process and treat all patients with the decolonization treatment regimen.

Conditions

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MRSA Colonization

Keywords

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MRSA decolonization MRSA subtyping MRSA infection rates

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chlorhexidine, Mupirocin

Chlorhexidine baths and intranasal Mupirocin ointment daily for 5 days

Group Type ACTIVE_COMPARATOR

Chlorhexidine, Mupirocin

Intervention Type DRUG

Chlorhexidine baths and intranasal mupirocin ointment once daily for five days

Soap baths, Lubricating jelly

Soap and water baths with lubricating jelly to each nare daily for 5 days

Group Type PLACEBO_COMPARATOR

Soap baths, Lubricating Jelly

Intervention Type DRUG

Soap and water baths with lubricating jelly to the nares, once daily for 5 days

Interventions

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Chlorhexidine, Mupirocin

Chlorhexidine baths and intranasal mupirocin ointment once daily for five days

Intervention Type DRUG

Soap baths, Lubricating Jelly

Soap and water baths with lubricating jelly to the nares, once daily for 5 days

Intervention Type DRUG

Other Intervention Names

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Hibiclens Bactroban

Eligibility Criteria

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Inclusion Criteria

* colonized with MRSA at admission
* age of 18 years or older
* admitted directly to the ICU from either the ED or the OR with trauma-related injuries

Exclusion Criteria

* active or recent known history of MRSA infection
* previous institutionalization
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

University of Tennessee

OTHER

Sponsor Role lead

Responsible Party

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Laura Brown

Research Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert A Maxwell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Locations

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Erlanger Hospital

Chattanooga, Tennessee, United States

Site Status

Countries

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United States

References

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Croft CA, Mejia VA, Barker DE, Maxwell RA, Dart BW, Smith PW, Burns RP. Methicillin-resistant Staphylococcus aureus in a trauma population: does colonization predict infection? Am Surg. 2009 Jun;75(6):458-61; discussion 461-2.

Reference Type BACKGROUND
PMID: 19545092 (View on PubMed)

Other Identifiers

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NTI-TRA-10-020

Identifier Type: -

Identifier Source: org_study_id