MRSA in a Trauma Population: Does Decolonization Prevent Infection?

NCT01820455 | Completed

• 1 other identifier: NTI-TRA-10-020
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

MRSA Colonization

Keywords

MRSA decolonization; MRSA subtyping; MRSA infection rates

Outcome Measures

Primary Outcomes (1)

• Number of patients decolonized following treatment

  Measurement of decolonization of MRSA as determined by polymerase chain reaction (PCR) from the nares of critically ill trauma population following treatment.

  Up to 24 months

Secondary Outcomes (2)

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

  up to 24 months

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

  up to 24 months

Study Arms (2)

Chlorhexidine, Mupirocin

ACTIVE COMPARATOR

Chlorhexidine baths and intranasal Mupirocin ointment daily for 5 days

Drug: Chlorhexidine, Mupirocin

Soap baths, Lubricating jelly

PLACEBO COMPARATOR

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

Drug: Soap baths, Lubricating Jelly

Interventions

Chlorhexidine, Mupirocin DRUG

Chlorhexidine baths and intranasal mupirocin ointment once daily for five days

Also known as: Hibiclens, Bactroban

Chlorhexidine, Mupirocin

Soap baths, Lubricating Jelly DRUG

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

Soap baths, Lubricating jelly

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• active or recent known history of MRSA infection
• previous institutionalization

Sponsors & Collaborators

• University of Tennessee: lead
• United States Department of Defense: collaborator

Study Sites (1)

Erlanger Hospital

Chattanooga, Tennessee, 37403, United States

Location

Related Publications (1)

• 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.

  PMID: 19545092 BACKGROUND

MeSH Terms

Interventions

Chlorhexidine; Mupirocin; chlorhexidine gluconate

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Epoxy Compounds; Ethers, Cyclic; Ethers; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids

Study Officials

• Robert A Maxwell, MD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: March 28, 2013
• Study Start: January 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

US (1)