MRSA in a Trauma Population: Does Decolonization Prevent Infection?

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

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.

Study Overview

• Status: Completed
• Conditions: MRSA Colonization
• Intervention / Treatment: Drug: Chlorhexidine, Mupirocin; Drug: Soap baths, Lubricating Jelly

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Bactroban; Hibiclens
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of decolonized patients who develop further infections versus number of infections developed by patients who remain colonized	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.	up to 24 months
Evaluate the genotype and virulence factors of initial colonization and additional MRSA sources	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.	up to 24 months

Collaborators and Investigators

• Sponsor: University of Tennessee
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Robert A Maxwell, MD, University of Tennessee

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: March 20, 2013
• First Submitted That Met QC Criteria: March 25, 2013
• First Posted (Estimate): March 28, 2013

Study Record Updates

• Last Update Posted (Estimate): December 18, 2014
• Last Update Submitted That Met QC Criteria: December 16, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: MRSA decolonization; MRSA subtyping; MRSA infection rates
• Additional Relevant MeSH Terms: Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Dermatologic Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Disinfectants; Mupirocin; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: NTI-TRA-10-020