MRSA in a Trauma Population: Does Decolonization Prevent Infection?
Status: | Completed |
---|---|
Conditions: | Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/14/2017 |
Start Date: | January 2012 |
End Date: | March 2014 |
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.
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.
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.
patients, the protocol would be altered to eliminate the randomization process and treat all
patients with the decolonization treatment regimen.
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
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