Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Susan Huang, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01209234
First received: September 23, 2010
Last updated: February 28, 2014
Last verified: February 2014

September 23, 2010
February 28, 2014
January 2011
June 2014   (final data collection date for primary outcome measure)
Time to MRSA infection [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Time in days to MRSA inpatient or outpatient infection
Same as current
Complete list of historical versions of study NCT01209234 on ClinicalTrials.gov Archive Site
  • Rehospitalization due to MRSA infection [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Time in days to rehospitalization due to MRSA infection
  • Cost and cost savings associated with post-discharge MRSA decolonization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Medical and non-medical costs of MRSA infection within the 1 year follow up period
  • Number of MRSA infections [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Event count of outpatient and inpatient MRSA infections occurring after enrollment
Same as current
Not Provided
Not Provided
 
Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance
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-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.

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Methicillin-resistant Staphylococcus Aureus
  • 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.
  • Active Comparator: 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.
    Intervention: Drug: MRSA Decolonization
  • Active Comparator: Education Arm
    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.
    Intervention: Behavioral: Standard-of-Care Education

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2200
June 2015
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01209234
2010-7710
Yes
Susan Huang, University of California, Irvine
University of California, Irvine
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Susan S Huang, MD, MPH University of California, Irivne - School of Medicine
University of California, Irvine
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP