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MRSA in a Trauma Population: Does Decolonization Prevent Infection?

Information source: University of Tennessee
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: MRSA Colonization

Intervention: Chlorhexidine, Mupirocin (Drug); Soap baths, Lubricating Jelly (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Tennessee

Official(s) and/or principal investigator(s):
Robert A Maxwell, MD, Principal Investigator, Affiliation: University of Tennessee

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of patients decolonized following treatment

Secondary outcome:

Number of decolonized patients who develop further infections versus number of infections developed by patients who remain colonized

Evaluate the genotype and virulence factors of initial colonization and additional MRSA sources

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Erlanger Hospital, Chattanooga, Tennessee 37403, United States
Additional Information

Related publications:

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.

Starting date: January 2012
Last updated: December 16, 2014

Page last updated: August 23, 2015

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