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Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance

Information source: University of California, Irvine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Methicillin-resistant Staphylococcus Aureus

Intervention: Standard-of-Care Education (Behavioral); MRSA Decolonization (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: University of California, Irvine

Official(s) and/or principal investigator(s):
Susan S Huang, MD, MPH, Principal Investigator, Affiliation: University of California, Irivne - School of Medicine

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.

Clinical Details

Official title: Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Time to MRSA infection

Secondary outcome:

Rehospitalization due to MRSA infection

Cost and cost savings associated with post-discharge MRSA decolonization

Number of MRSA infections

Time to all-cause infection (Steering Committee modified Oct 2011)

Number of all-cause infections (Steering Committee modified Oct 2011)

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 1) At least 18 years old

- 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:

- 1) Known allergies to chlorhexidine or mupirocin

Locations and Contacts

Covington Care Center, Aliso Viejo, California 92656, United States

West Anaheim Extended Care, Anaheim, California 92804, United States

Downey Regional Medical Center, Downey, California 90241, United States

Fountain Valley Regional Hospital & Medical Center, Fountain Valley, California 92708, United States

Orange Coast Memorial Medical Center, Fountain Valley, California 92708, United States

St. Jude Medical Center, Fullerton, California 92835, United States

Chapman Care Center, Garden Grove, California 92840, United States

Pacific Haven HealthCare Center, Garden Grove, California 92843, United States

Regents Point at Windcrest, Irvine, California 92612, United States

Saddleback Memorial Medical Center - Laguna Hills, Laguna Hills, California 92653, United States

Long Beach Memorial Medical Center, Long Beach, California 90806, United States

St. Mary Medical Center, Long Beach, California 90813, United States

Mission Hospital, Mission Viejo, California 92691, United States

Hoag Memorial Hospital Presbyterian, Newport Beach, California 92658, United States

Villa Elena Health Care Center, Norwalk, California 90650, United States

UC Irvine Medical Center, Orange, California 92868, United States

Saddleback Memorial Medical Center - San Clemente, San Clemente, California 92673, United States

Little Company of Mary - San Pedro, San Pedro, California 90732, United States

Country Villa Plaza, Santa Ana, California 92707, United States

Royale Healthcare, Santa Ana, California 92707, United States

Providence Little Company of Mary Medical Center, Torrance, California 90732, United States

Torrance Memorial Medical Center, Torrance, California 90505, United States

Harbor-UCLA Medical Center, Torrence, California 90502, United States

Ventura County Medical Center, Ventura, California 93003, United States

Additional Information

Study information

Related publications:

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. 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.

Starting date: January 2011
Last updated: March 12, 2015

Page last updated: August 23, 2015

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