Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance (CLEAR)
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| ClinicalTrials.gov Identifier: NCT01209234 |
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Recruitment Status :
Completed
First Posted : September 27, 2010
Results First Posted : September 17, 2020
Last Update Posted : November 19, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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) |
| Actual Enrollment : | 2140 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 |
| Actual Primary Completion Date : | January 2019 |
| Actual Study Completion Date : | January 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. |
- Time to MRSA Infection [ Time Frame: 1 year ]Time in days to MRSA inpatient or outpatient infection (analyzed with the use of unadjusted Cox proportional-hazard models to identify time to infection; the results we are reporting are number of participants who had an infection event at one year post discharge)
- Time to All-cause Infection (Steering Committee Modified Oct 2011) [ Time Frame: 1 year ]Time in days to all-cause infection (analyzed with the use of unadjusted Cox proportional-hazard models to identify time to infection; the results we are reporting are number of participants who had an infection event at one year)
- Number of MRSA Infections [ Time Frame: 1 year ]Event count of outpatient and inpatient MRSA infections occurring after enrollment
- 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 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, Older Adult) |
| 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
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| Principal Investigator: | Susan S Huang, MD, MPH | University of California, Irivne - School of Medicine |
Documents provided by Susan Huang, University of California, Irvine:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Susan Huang, Director of Epidemiology and Infection Prevention, University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT01209234 |
| Other Study ID Numbers: |
2010-7710 |
| First Posted: | September 27, 2010 Key Record Dates |
| Results First Posted: | September 17, 2020 |
| Last Update Posted: | November 19, 2020 |
| Last Verified: | November 2020 |
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Methicillin-resistant Staphylococcus aureus MRSA |
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Staphylococcal Infections Gram-Positive Bacterial Infections Bacterial Infections |