Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance
- Conditions
- Methicillin-resistant Staphylococcus Aureus
- Interventions
- Drug: MRSA DecolonizationBehavioral: Standard-of-Care Education
- Registration Number
- NCT01209234
- Lead Sponsor
- University of California, Irvine
- Brief Summary
This randomized controlled trial will compare strategies to reduce the risk of methicillin-resistant Staphylococcus aureus (MRSA) infection and re-hospitalization in MRSA carriers. This trial will provide critical answers about the role of decolonization versus standard-of-care education in preventing MRSA infections in the large group of high risk MRSA-positive patients being discharged from hospitals. Findings could potentially impact best practice for the 1.8 million MRSA carriers who are discharged from US hospitals each year.
- Detailed Description
This randomized controlled trial will compare strategies to reduce the risk of methicillin-resistant Staphylococcus aureus (MRSA) infection and re-hospitalization in MRSA carriers. This trial will provide critical answers about the role of decolonization versus standard-of-care education in preventing MRSA infections in the large group of high risk MRSA+ patients being discharged from hospitals. Findings could potentially impact best practice for the 1.8 million MRSA carriers who are discharged from US hospitals each year.
Specific Aims:
Methicillin-resistant Staphylococcus aureus (MRSA) is arguably the most important single pathogen in healthcare-associated infection when accounting for virulence, prevalence, diversity of disease spectrum, and propensity for widespread transmission. MRSA infection causes or complicates 300,000 hospitalizations each year \[Klein, Smith, Laxminarayan\], a number which has doubled in the past five years. An additional 1.5 million hospitalized patients either acquire or already harbor the pathogen without current infection. Altogether, these 1.8 million MRSA inpatient carriers experience a high amount of MRSA invasive disease in the year following discharge. Due to increased delivery of complex medical care at home or other post-hospital settings, more and more patients experience serious healthcare-associated morbidity after hospital discharge.\[Huang, Platt; Huang, Hinrichsen, Stulgis et al.\] In fact, over 80% of patients admitted for MRSA infection have had prior healthcare exposures and are at high risk for repeated MRSA infection.\[Huang, Platt; Huang, Hinrichsen, Stulgis et al.; Klevens, Morrison, Nadle, et al.\]
Project CLEAR compares two strategies to reduce infection and re-hospitalization due to MRSA among patients being discharged from hospitals. Our trial will compare a long-term regimen aimed at eradicating MRSA body reservoirs with patient education on general hygiene and self care, which is the current standard of care. Our specific aims are:
* To conduct a randomized controlled trial of serial decolonization versus standard-of-care patient education among MRSA carriers upon hospital discharge to reduce post-discharge MRSA infection and re-hospitalization for one year
* To identify predictors of a) infection or re-hospitalization due to MRSA, and b) successful MRSA decolonization, including patient demographics, comorbidities, medical devices, risk behaviors, socioeconomic status, and colonizing MRSA genotype
* To estimate medical and non-medical costs of MRSA infection among MRSA carriers and evaluate the potential for cost savings associated with decolonization
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2140
-
- At least 18 years old
-
- Have had a positive culture (a type of test) for MRSA during recent hospital admission or within the 30 days prior to admission or following discharge
-
- Able to give consent or have a primary caregiver provide consent
-
- Able to bathe or shower or have this consistently performed by a willing caregiver
-
- Known allergies to chlorhexidine or mupirocin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MRSA Decolonization MRSA Decolonization Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month. Education Arm Standard-of-Care Education Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.
- Primary Outcome Measures
Name Time Method Time to MRSA Infection 1 year Time in days to MRSA inpatient or outpatient infection (analyzed with the use of unadjusted Cox proportional-hazard models to identify time to infection; the results we are reporting are number of participants who had an infection event at one year post discharge)
- Secondary Outcome Measures
Name Time Method Time to All-cause Infection (Steering Committee Modified Oct 2011) 1 year Time in days to all-cause infection (analyzed with the use of unadjusted Cox proportional-hazard models to identify time to infection; the results we are reporting are number of participants who had an infection event at one year)
Trial Locations
- Locations (24)
Pacific Haven HealthCare Center
🇺🇸Garden Grove, California, United States
West Anaheim Extended Care
🇺🇸Anaheim, California, United States
Orange Coast Memorial Medical Center
🇺🇸Fountain Valley, California, United States
St. Jude Medical Center
🇺🇸Fullerton, California, United States
Regents Point at Windcrest
🇺🇸Irvine, California, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Country Villa Plaza
🇺🇸Santa Ana, California, United States
Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Providence Little Company of Mary Medical Center
🇺🇸Torrance, California, United States
Covington Care Center
🇺🇸Aliso Viejo, California, United States
Downey Regional Medical Center
🇺🇸Downey, California, United States
Chapman Care Center
🇺🇸Garden Grove, California, United States
St. Mary Medical Center
🇺🇸Long Beach, California, United States
Saddleback Memorial Medical Center - Laguna Hills
🇺🇸Laguna Hills, California, United States
Mission Hospital
🇺🇸Mission Viejo, California, United States
Long Beach Memorial Medical Center
🇺🇸Long Beach, California, United States
Villa Elena Health Care Center
🇺🇸Norwalk, California, United States
UC Irvine Medical Center
🇺🇸Orange, California, United States
Royale Healthcare
🇺🇸Santa Ana, California, United States
Little Company of Mary - San Pedro
🇺🇸San Pedro, California, United States
Torrance Memorial Medical Center
🇺🇸Torrance, California, United States
Ventura County Medical Center
🇺🇸Ventura, California, United States
Fountain Valley Regional Hospital & Medical Center
🇺🇸Fountain Valley, California, United States
Saddleback Memorial Medical Center - San Clemente
🇺🇸San Clemente, California, United States