MRSA in a Trauma Population: Does Decolonization Prevent Infection?

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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MRSA Colonization

Intervention / Treatment
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* Drug: Chlorhexidine, Mupirocin
* Drug: Soap baths, Lubricating Jelly


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chlorhexidine, Mupirocin<br>Chlorhexidine baths and intranasal Mupirocin ointment daily for 5 days | Drug: Chlorhexidine, Mupirocin<br>* Chlorhexidine baths and intranasal mupirocin ointment once daily for five days<br>* Other names: Bactroban;|
| Placebo Comparator: Soap baths, Lubricating jelly<br>Soap and water baths with lubricating jelly to each nare daily for 5 days | Drug: Soap baths, Lubricating Jelly<br>* Soap and water baths with lubricating jelly to the nares, once daily for 5 days<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRSA decolonization, MRSA subtyping, MRSA infection rates