Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance

Methicillin-resistant Staphylococcus Aureus Clinical Trial

— CLEAR  

Official title:

Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01209234
• Other study ID #: 2010-7710
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: January 2019

Study information

• Verified date: January 2023
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2140
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Methicillin-resistant Staphylococcus Aureus
• Staphylococcal Infections

Intervention

Behavioral:
• 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.

Drug:
• 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.

Locations

Country	Name	City	State
United States	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	Harbor-UCLA Medical Center	Torrance	California
United States	Providence Little Company of Mary Medical Center	Torrance	California
United States	Torrance Memorial Medical Center	Torrance	California
United States	Ventura County Medical Center	Ventura	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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.

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of MRSA Infections	Event count of outpatient and inpatient MRSA infections occurring after enrollment	1 year
Other	Rehospitalization Due to MRSA Infection	Time in days to rehospitalization due to MRSA infection	1 year
Other	Cost and Cost Savings Associated With Post-discharge MRSA Decolonization	Medical and non-medical costs of MRSA infection within the 1 year follow up period	1 year
Other	Number of All-cause Infections (Steering Committee Modified Oct 2011)	Event count of all-cause infections occurring after enrollment	1 year
Primary	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	Time to All-cause Infection (Steering Committee Modified Oct 2011)	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)	1 year