Clinical trial NCT01820455: MRSA in a Trauma Population: Does Decolonization Prevent Infection?
Official title: Methicillin-resistant Staphylococcus Aureus in a Trauma Population: Does Decolonization Prevent Infection?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: MRSA Colonization
Keywords: MRSA decolonization
MRSA subtyping
MRSA infection rates
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2013-03-28
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients decolonized following treatment
timeFrame: Up to 24 months
Secondary outcomes:
measure: Number of decolonized patients who develop further infections versus number of infections developed by patients who remain colonized
timeFrame: up to 24 months
measure: Evaluate the genotype and virulence factors of initial colonization and additional MRSA sources
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: Erlanger Hospital
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Robert A Maxwell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.