Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance

NCT01209234 | Completed Results DMC

• 1 other identifier: 2010-7710
• Study Type: interventional
• Target: 2,140
• Locations: 1 country
• Sites: 24

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.

Conditions

Methicillin-resistant Staphylococcus Aureus

Keywords

Methicillin-resistant Staphylococcus aureus; MRSA

Outcome Measures

Primary Outcomes (1)

• Time to MRSA Infection

  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)

  1 year

Secondary Outcomes (1)

• Time to All-cause Infection (Steering Committee Modified Oct 2011)

  1 year

Other Outcomes (4)

• Number of MRSA Infections

  1 year

• Rehospitalization Due to MRSA Infection

  1 year

• Cost and Cost Savings Associated With Post-discharge MRSA Decolonization

  1 year

Study Arms (2)

MRSA Decolonization

ACTIVE COMPARATOR

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.

Drug: MRSA Decolonization

Education Arm

ACTIVE COMPARATOR

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.

Behavioral: Standard-of-Care Education

Interventions

Standard-of-Care Education BEHAVIORAL

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.

Education Arm

MRSA Decolonization DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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

You may not qualify if:

• \) Known allergies to chlorhexidine or mupirocin

Sponsors & Collaborators

• University of California, Irvine: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (24)

Covington Care Center

Aliso Viejo, California, 92656, United States

Location

West Anaheim Extended Care

Anaheim, California, 92804, United States

Location

Downey Regional Medical Center

Downey, California, 90241, United States

Location

Fountain Valley Regional Hospital & Medical Center

Fountain Valley, California, 92708, United States

Location

Orange Coast Memorial Medical Center

Fountain Valley, California, 92708, United States

Location

St. Jude Medical Center

Fullerton, California, 92835, United States

Location

Chapman Care Center

Garden Grove, California, 92840, United States

Location

Pacific Haven HealthCare Center

Garden Grove, California, 92843, United States

Location

Regents Point at Windcrest

Irvine, California, 92612, United States

Location

Saddleback Memorial Medical Center - Laguna Hills

Laguna Hills, California, 92653, United States

Location

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

St. Mary Medical Center

Long Beach, California, 90813, United States

Location

Mission Hospital

Mission Viejo, California, 92691, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92658, United States

Location

Villa Elena Health Care Center

Norwalk, California, 90650, United States

Location

UC Irvine Medical Center

Orange, California, 92868, United States

Location

Saddleback Memorial Medical Center - San Clemente

San Clemente, California, 92673, United States

Location

Little Company of Mary - San Pedro

San Pedro, California, 90732, United States

Location

Country Villa Plaza

Santa Ana, California, 92707, United States

Location

Royale Healthcare

Santa Ana, California, 92707, United States

Location

Torrance Memorial Medical Center

Torrance, California, 90505, United States

Location

Providence Little Company of Mary Medical Center

Torrance, California, 90732, United States

Location

Harbor-UCLA Medical Center

Torrence, California, 90502, United States

Location

Ventura County Medical Center

Ventura, California, 93003, United States

Location

Related Publications (5)

• 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.

  PMID: 18258033 BACKGROUND

• 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.

  PMID: 12539068 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 17940231 BACKGROUND

• 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.

  PMID: 30763195 DERIVED

Results Point of Contact

• Title: Susan Huang, Principal Investigator & Medical Director of Epidemiology and Infection Prevention
• Organization: University of California, Irvine

sshuang@uci.edu

949-824-5073

Study Officials

• Susan S Huang, MD, MPH

  University of California, Irivne - School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Epidemiology and Infection Prevention

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: September 27, 2010
• Study Start: January 1, 2011
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: November 21, 2025
• Results First Posted: September 17, 2020

Record last verified: 2025-11

Locations

US (24)