Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance

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

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