Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance
NCT ID: NCT01209234
Last Updated: 2025-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
2140 participants
INTERVENTIONAL
2011-01-31
2019-01-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 2\) 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
* 3\) Able to give consent or have a primary caregiver provide consent
* 4\) Able to bathe or shower or have this consistently performed by a willing caregiver
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Agency for Healthcare Research and Quality (AHRQ)
FED
University of California, Irvine
OTHER
Responsible Party
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Susan Huang
Director of Epidemiology and Infection Prevention
Principal Investigators
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Susan S Huang, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, Irivne - School of Medicine
Locations
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Covington Care Center
Aliso Viejo, California, United States
West Anaheim Extended Care
Anaheim, California, United States
Downey Regional Medical Center
Downey, California, United States
Fountain Valley Regional Hospital & Medical Center
Fountain Valley, California, United States
Orange Coast Memorial Medical Center
Fountain Valley, California, United States
St. Jude Medical Center
Fullerton, California, United States
Chapman Care Center
Garden Grove, California, United States
Pacific Haven HealthCare Center
Garden Grove, California, United States
Regents Point at Windcrest
Irvine, California, United States
Saddleback Memorial Medical Center - Laguna Hills
Laguna Hills, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
St. Mary Medical Center
Long Beach, California, United States
Mission Hospital
Mission Viejo, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Villa Elena Health Care Center
Norwalk, California, United States
UC Irvine Medical Center
Orange, California, United States
Saddleback Memorial Medical Center - San Clemente
San Clemente, California, United States
Little Company of Mary - San Pedro
San Pedro, California, United States
Country Villa Plaza
Santa Ana, California, United States
Royale Healthcare
Santa Ana, California, United States
Torrance Memorial Medical Center
Torrance, California, United States
Providence Little Company of Mary Medical Center
Torrance, California, United States
Harbor-UCLA Medical Center
Torrence, California, United States
Ventura County Medical Center
Ventura, California, United States
Countries
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References
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Klein E, Smith DL, Laxminarayan R. Hospitalizations and deaths caused by methicillin-resistant Staphylococcus aureus, United States, 1999-2005. Emerg Infect Dis. 2007 Dec;13(12):1840-6. doi: 10.3201/eid1312.070629.
Huang SS, Platt R. Risk of methicillin-resistant Staphylococcus aureus infection after previous infection or colonization. Clin Infect Dis. 2003 Feb 1;36(3):281-5. doi: 10.1086/345955. Epub 2003 Jan 17.
Huang SS, Hinrichsen VH, Stulgis L, Miroshnik I, Datta R, Watson K, Platt R. Methicillin-resistant Staphylococcus aureus Infection in the Year Following Detection of Carriage (oral presentation). Society of Healthcare Epidemiology of America Annual Meeting (Chicago, IL), March 18-21, 2006.
Klevens RM, Morrison MA, Nadle J, Petit S, Gershman K, Ray S, Harrison LH, Lynfield R, Dumyati G, Townes JM, Craig AS, Zell ER, Fosheim GE, McDougal LK, Carey RB, Fridkin SK; Active Bacterial Core surveillance (ABCs) MRSA Investigators. Invasive methicillin-resistant Staphylococcus aureus infections in the United States. JAMA. 2007 Oct 17;298(15):1763-71. doi: 10.1001/jama.298.15.1763.
Huang SS, Singh R, McKinnell JA, Park S, Gombosev A, Eells SJ, Gillen DL, Kim D, Rashid S, Macias-Gil R, Bolaris MA, Tjoa T, Cao C, Hong SS, Lequieu J, Cui E, Chang J, He J, Evans K, Peterson E, Simpson G, Robinson P, Choi C, Bailey CC Jr, Leo JD, Amin A, Goldmann D, Jernigan JA, Platt R, Septimus E, Weinstein RA, Hayden MK, Miller LG; Project CLEAR Trial. Decolonization to Reduce Postdischarge Infection Risk among MRSA Carriers. N Engl J Med. 2019 Feb 14;380(7):638-650. doi: 10.1056/NEJMoa1716771.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2010-7710
Identifier Type: -
Identifier Source: org_study_id
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