Clinical trial NCT01209234: Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance
Official title: Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methicillin-resistant Staphylococcus Aureus
Keywords: Methicillin-resistant Staphylococcus aureus
MRSA
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2010-09-27
Enrollment: 2140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility 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

Primary outcomes:
measure: Time to MRSA Infection
timeFrame: 1 year
Secondary outcomes:
measure: Time to All-cause Infection (Steering Committee Modified Oct 2011)
timeFrame: 1 year
Other outcomes:
measure: Number of MRSA Infections
timeFrame: 1 year
measure: Rehospitalization Due to MRSA Infection
timeFrame: 1 year
measure: Cost and Cost Savings Associated With Post-discharge MRSA Decolonization
timeFrame: 1 year
measure: Number of All-cause Infections (Steering Committee Modified Oct 2011)
timeFrame: 1 year
Locations:
city: Aliso Viejo
country: United States
facility: Covington Care Center
state: California
city: Anaheim
country: United States
facility: West Anaheim Extended Care
state: California
city: Downey
country: United States
facility: Downey Regional Medical Center
state: California
city: Fountain Valley
country: United States
facility: Fountain Valley Regional Hospital & Medical Center
state: California
city: Fountain Valley
country: United States
facility: Orange Coast Memorial Medical Center
state: California
city: Fullerton
country: United States
facility: St. Jude Medical Center
state: California
city: Garden Grove
country: United States
facility: Chapman Care Center
state: California
city: Garden Grove
country: United States
facility: Pacific Haven HealthCare Center
state: California
city: Irvine
country: United States
facility: Regents Point at Windcrest
state: California
city: Laguna Hills
country: United States
facility: Saddleback Memorial Medical Center - Laguna Hills
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Long Beach
country: United States
facility: St. Mary Medical Center
state: California
city: Mission Viejo
country: United States
facility: Mission Hospital
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Norwalk
country: United States
facility: Villa Elena Health Care Center
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
city: San Clemente
country: United States
facility: Saddleback Memorial Medical Center - San Clemente
state: California
city: San Pedro
country: United States
facility: Little Company of Mary - San Pedro
state: California
city: Santa Ana
country: United States
facility: Country Villa Plaza
state: California
city: Santa Ana
country: United States
facility: Royale Healthcare
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Torrance
country: United States
facility: Providence Little Company of Mary Medical Center
state: California
city: Ventura
country: United States
facility: Ventura County Medical Center
state: California
Study officials:
affiliation: University of California, Irivne - School of Medicine
name: Susan S Huang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.