Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance (CLEAR)
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ClinicalTrials.gov Identifier: NCT01209234 |
Recruitment Status
:
Active, not recruiting
First Posted
: September 27, 2010
Last Update Posted
: February 24, 2017
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Condition or disease | Intervention/treatment | Phase |
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Methicillin-resistant Staphylococcus Aureus | Behavioral: Standard-of-Care Education Drug: MRSA Decolonization | Not Applicable |
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 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 |
Arm | Intervention/treatment |
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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.
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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.
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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.
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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.
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- Time to MRSA infection [ Time Frame: 1 year ]Time in days to MRSA inpatient or outpatient infection
- Rehospitalization due to MRSA infection [ Time Frame: 1 year ]Time in days to rehospitalization due to MRSA infection
- 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
- Number of MRSA infections [ Time Frame: 1 year ]Event count of outpatient and inpatient MRSA infections occurring after enrollment
- Time to all-cause infection (Steering Committee modified Oct 2011) [ Time Frame: 1 year ]Time in days to all-cause infection
- Number of all-cause infections (Steering Committee modified Oct 2011) [ Time Frame: 1 year ]Event count of all-cause infections occurring after enrollment

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

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
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 | |
Torrance Memorial Medical Center | |
Torrance, California, United States, 90505 | |
Providence Little Company of Mary Medical Center | |
Torrance, California, United States, 90732 | |
Harbor-UCLA Medical Center | |
Torrence, California, United States, 90502 | |
Ventura County Medical Center | |
Ventura, California, United States, 93003 |
Principal Investigator: | Susan S Huang, MD, MPH | University of California, Irivne - School of Medicine |
Publications:
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: | February 24, 2017 |
Last Verified: | February 2017 |
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 |