MRSA in a Trauma Population: Does Decolonization Prevent Infection?

MRSA Colonization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01820455
• Other study ID #: NTI-TRA-10-020
• Status: Completed
• Phase: N/A
• First received: March 20, 2013
• Last updated: December 16, 2014
• Start date: January 2012
• Est. completion date: March 2014

Study information

• Verified date: December 2014
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• MRSA Colonization

Intervention

Drug:
• Chlorhexidine, Mupirocin
Chlorhexidine baths and intranasal mupirocin ointment once daily for five days
• Soap baths, Lubricating Jelly
Soap and water baths with lubricating jelly to the nares, once daily for 5 days

Locations

Country	Name	City	State
United States	Erlanger Hospital	Chattanooga	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Tennessee	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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