Summary

for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion
Susan Huang

Description

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.

Details

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

Keywords

Methicillin-resistant Staphylococcus Aureus MRSA Staphylococcal Infections Anti-Bacterial Agents MRSA Decolonization

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 1) Known allergies to chlorhexidine or mupirocin

Locations

  • UC Irvine Medical Center
    Orange California 92868 United States
  • Regents Point at Windcrest
    Irvine California 92612 United States
  • Hoag Memorial Hospital Presbyterian
    Newport Beach California 92658 United States
  • Country Villa Plaza
    Santa Ana California 92707 United States
  • Royale Healthcare
    Santa Ana California 92707 United States
  • Covington Care Center
    Aliso Viejo California 92656 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
  • Pacific Haven HealthCare Center
    Garden Grove California 92843 United States
  • Saddleback Memorial Medical Center - Laguna Hills
    Laguna Hills California 92653 United States

Lead Scientist

  • Susan Huang
    Professor, Medicine. Authored (or co-authored) 151 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT01209234
Study Type
Interventional
Last Updated