ClinicalTrials.gov
ClinicalTrials.gov Menu

Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance (CLEAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01209234
Recruitment Status : Active, not recruiting
First Posted : September 27, 2010
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Susan Huang, University of California, Irvine

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Methicillin-resistant Staphylococcus Aureus Behavioral: Standard-of-Care Education Drug: MRSA Decolonization Not Applicable

Detailed 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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance
Study Start Date : January 2011
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics MRSA

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 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: 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.
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Time to MRSA infection [ Time Frame: 1 year ]
    Time in days to MRSA inpatient or outpatient infection


Secondary Outcome Measures :
  1. Rehospitalization due to MRSA infection [ Time Frame: 1 year ]
    Time in days to rehospitalization due to MRSA infection

  2. Cost and cost savings associated with post-discharge MRSA decolonization [ Time Frame: 1 year ]
    Medical and non-medical costs of MRSA infection within the 1 year follow up period

  3. Number of MRSA infections [ Time Frame: 1 year ]
    Event count of outpatient and inpatient MRSA infections occurring after enrollment

  4. Time to all-cause infection (Steering Committee modified Oct 2011) [ Time Frame: 1 year ]
    Time in days to all-cause infection

  5. Number of all-cause infections (Steering Committee modified Oct 2011) [ Time Frame: 1 year ]
    Event count of all-cause infections occurring after enrollment


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01209234


Locations
United States, California
Covington Care Center
Aliso Viejo, California, United States, 92656
West Anaheim Extended Care
Anaheim, California, United States, 92804
Downey Regional Medical Center
Downey, California, United States, 90241
Fountain Valley Regional Hospital & Medical Center
Fountain Valley, California, United States, 92708
Orange Coast Memorial Medical Center
Fountain Valley, California, United States, 92708
St. Jude Medical Center
Fullerton, California, United States, 92835
Chapman Care Center
Garden Grove, California, United States, 92840
Pacific Haven HealthCare Center
Garden Grove, California, United States, 92843
Regents Point at Windcrest
Irvine, California, United States, 92612
Saddleback Memorial Medical Center - Laguna Hills
Laguna Hills, California, United States, 92653
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
St. Mary Medical Center
Long Beach, California, United States, 90813
Mission Hospital
Mission Viejo, California, United States, 92691
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
Villa Elena Health Care Center
Norwalk, California, United States, 90650
UC Irvine Medical Center
Orange, California, United States, 92868
Saddleback Memorial Medical Center - San Clemente
San Clemente, California, United States, 92673
Little Company of Mary - San Pedro
San Pedro, California, United States, 90732
Country Villa Plaza
Santa Ana, California, United States, 92707
Royale Healthcare
Santa Ana, California, United States, 92707
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Torrance Memorial Medical Center
Torrance, California, United States, 90505
Providence Little Company of Mary Medical Center
Torrance, California, United States, 90732
Ventura County Medical Center
Ventura, California, United States, 93003
Sponsors and Collaborators
University of California, Irvine
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Susan S Huang, MD, MPH University of California, Irivne - School of Medicine
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:
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.

Responsible Party: Susan Huang, Director of Epidemiology and Infection Prevention, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01209234     History of Changes
Other Study ID Numbers: 2010-7710
First Posted: September 27, 2010    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018

Keywords provided by Susan Huang, University of California, Irvine:
Methicillin-resistant Staphylococcus aureus
MRSA

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents