MRSA in a Trauma Population: Does Decolonization Prevent Infection?

Sponsor

University of Tennessee (Other)

Overall Status

Completed

CT.gov ID

NCT01820455

Collaborator

United States Department of Defense (U.S. Fed)

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
MRSA Colonization	Drug: Chlorhexidine, Mupirocin Drug: Soap baths, Lubricating Jelly	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Methicillin-resistant Staphylococcus Aureus in a Trauma Population: Does Decolonization Prevent Infection?

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Chlorhexidine, Mupirocin Chlorhexidine baths and intranasal Mupirocin ointment daily for 5 days	Drug: Chlorhexidine, Mupirocin Chlorhexidine baths and intranasal mupirocin ointment once daily for five days Other Names: Hibiclens Bactroban
Placebo Comparator: Soap baths, Lubricating jelly Soap and water baths with lubricating jelly to each nare daily for 5 days	Drug: Soap baths, Lubricating Jelly Soap and water baths with lubricating jelly to the nares, once daily for 5 days

Arm

Intervention/Treatment

Active Comparator: Chlorhexidine, Mupirocin

Chlorhexidine baths and intranasal Mupirocin ointment daily for 5 days

Drug: Chlorhexidine, Mupirocin

Chlorhexidine baths and intranasal mupirocin ointment once daily for five days

Other Names:

Hibiclens

Bactroban

Placebo Comparator: Soap baths, Lubricating jelly

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

Drug: Soap baths, Lubricating Jelly

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

Outcome Measures

Primary Outcome Measures

Number of patients decolonized following treatment [Up to 24 months]
Measurement of decolonization of MRSA as determined by polymerase chain reaction (PCR) from the nares of critically ill trauma population following treatment.

Secondary Outcome Measures

Number of decolonized patients who develop further infections versus number of infections developed by patients who remain colonized [up to 24 months]
Evaluate the difference between the number of patients who are decolonized following treatment who later develop invasive MRSA infections versus those who remain colonized and develop infections.
Evaluate the genotype and virulence factors of initial colonization and additional MRSA sources [up to 24 months]
Evaluate the genotypes of the initial MRSA sampled and additional sources developed by the patient. This will determine if patients are developing additional infections from outside sources or from the same strain of MRSA with which they were originally colonized.