MRSA in a Trauma Population: Does Decolonization Prevent Infection?

University of Tennessee

Status: Completed

Conditions: MRSA Colonization

Treatments: Drug: Chlorhexidine, Mupirocin; Drug: Soap baths, Lubricating Jelly

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01820455

NTI-TRA-10-020

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups, including a placebo group

Chlorhexidine, Mupirocin

Active Comparator group

Description:

Chlorhexidine baths and intranasal Mupirocin ointment daily for 5 days

Treatment:

Drug: Chlorhexidine, Mupirocin

Soap baths, Lubricating jelly

Placebo Comparator group

Description:

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

Treatment:

Drug: Soap baths, Lubricating Jelly