MRSA in a Trauma Population: Does Decolonization Prevent Infection?
Primary Purpose
MRSA Colonization
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine, Mupirocin
Soap baths, Lubricating Jelly
Sponsored by
About this trial
This is an interventional treatment trial for MRSA Colonization focused on measuring MRSA decolonization, MRSA subtyping, MRSA infection rates
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
Sites / Locations
- Erlanger Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Chlorhexidine, Mupirocin
Soap baths, Lubricating jelly
Arm Description
Chlorhexidine baths and intranasal Mupirocin ointment daily for 5 days
Soap and water baths with lubricating jelly to each nare daily for 5 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01820455
First Posted
March 20, 2013
Last Updated
December 16, 2014
Sponsor
University of Tennessee
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT01820455
Brief Title
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
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tennessee
Collaborators
United States Department of Defense
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MRSA Colonization
Keywords
MRSA decolonization, MRSA subtyping, MRSA infection rates
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chlorhexidine, Mupirocin
Arm Type
Active Comparator
Arm Description
Chlorhexidine baths and intranasal Mupirocin ointment daily for 5 days
Arm Title
Soap baths, Lubricating jelly
Arm Type
Placebo Comparator
Arm Description
Soap and water baths with lubricating jelly to each nare daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine, Mupirocin
Other Intervention Name(s)
Hibiclens, Bactroban
Intervention Description
Chlorhexidine baths and intranasal mupirocin ointment once daily for five days
Intervention Type
Drug
Intervention Name(s)
Soap baths, Lubricating Jelly
Intervention Description
Soap and water baths with lubricating jelly to the nares, once daily for 5 days
Primary Outcome Measure Information:
Title
Number of patients decolonized following treatment
Description
Measurement of decolonization of MRSA as determined by polymerase chain reaction (PCR) from the nares of critically ill trauma population following treatment.
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Number of decolonized patients who develop further infections versus number of infections developed by patients who remain colonized
Description
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.
Time Frame
up to 24 months
Title
Evaluate the genotype and virulence factors of initial colonization and additional MRSA sources
Description
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.
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A Maxwell, MD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erlanger Hospital
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19545092
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.
Results Reference
background
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MRSA in a Trauma Population: Does Decolonization Prevent Infection?
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