Methicillin-resistant Staphylococcus Aureus
Conditions
Keywords
Methicillin-resistant Staphylococcus aureus, MRSA
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.
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
Interventions
BEHAVIORALStandard-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.
DRUGMRSA 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.
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to MRSA Infection | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to All-cause Infection (Steering Committee Modified Oct 2011) | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of MRSA Infections | 1 year | Event count of outpatient and inpatient MRSA infections occurring after enrollment |
| Rehospitalization Due to MRSA Infection | 1 year | Number of participants experiencing rehospitalization due to MRSA infection (first only) |
| Cost and Cost Savings Associated With Post-discharge MRSA Decolonization | 1 year | Medical and non-medical costs of MRSA infection within the 1 year follow up period |
| Number of All-cause Infections | 1 year | Event count of all-cause infections occurring after enrollment |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred between January 10, 2011 and January 2, 2014, during inpatient admissions in 17 hospitals and 7 nursing homes in Southern California.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 1,058 |
| 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.
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. | 1,063 |
| Total | 2,121 |
Baseline characteristics
| Characteristic | MRSA Decolonization | Education Arm | Total |
|---|---|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 17 | 56 years STANDARD_DEVIATION 17 | 56 years STANDARD_DEVIATION 17 |
| Race/Ethnicity, Customized Race American Indian | 6 Participants | 6 Participants | 12 Participants |
| Race/Ethnicity, Customized Race Asian | 47 Participants | 58 Participants | 105 Participants |
| Race/Ethnicity, Customized Race Black | 132 Participants | 124 Participants | 256 Participants |
| Race/Ethnicity, Customized Race Other | 20 Participants | 21 Participants | 41 Participants |
| Race/Ethnicity, Customized Race Unknown/Not Reported | 13 Participants | 10 Participants | 23 Participants |
| Race/Ethnicity, Customized Race White | 840 Participants | 844 Participants | 1684 Participants |
| Region of Enrollment United States | 1058 Participants | 1063 Participants | 2121 Participants |
| Sex: Female, Male Female | 493 Participants | 480 Participants | 973 Participants |
| Sex: Female, Male Male | 565 Participants | 583 Participants | 1148 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,058 | 0 / 1,063 |
| other Total, other adverse events | 48 / 1,058 | 0 / 1,063 |
| serious Total, serious adverse events | 0 / 1,058 | 0 / 1,063 |
Outcome results
Primary
Time to MRSA Infection
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 frame: 1 year
Population: Outcomes were analyzed according to the as-treated adherence strata (fully adherent, partially adherent, and nonadherent participant-time)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MRSA Decolonization | Time to MRSA Infection | MRSA Infection defined by CDC Criteria | 67 Participants |
| MRSA Decolonization | Time to MRSA Infection | MRSA Infection defined by Clinical Criteria | 68 Participants |
| Education Arm | Time to MRSA Infection | MRSA Infection defined by CDC Criteria | 98 Participants |
| Education Arm | Time to MRSA Infection | MRSA Infection defined by Clinical Criteria | 98 Participants |
p-value: 0.02695% CI: [0.52, 0.96]Regression, Cox
Secondary
Time to All-cause Infection (Steering Committee Modified Oct 2011)
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)
Time frame: 1 year
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MRSA Decolonization | Time to All-cause Infection (Steering Committee Modified Oct 2011) | All-Cause Infection defined by Clinical Criteria | 246 Participants |
| MRSA Decolonization | Time to All-cause Infection (Steering Committee Modified Oct 2011) | All-Cause Infection defined by CDC Criteria | 207 Participants |
| Education Arm | Time to All-cause Infection (Steering Committee Modified Oct 2011) | All-Cause Infection defined by CDC Criteria | 252 Participants |
| Education Arm | Time to All-cause Infection (Steering Committee Modified Oct 2011) | All-Cause Infection defined by Clinical Criteria | 298 Participants |
p-value: 0.06195% CI: [0.7, 1.01]Regression, Cox
p-value: 0.03595% CI: [0.7, 0.99]Regression, Cox
Other Pre-specified
Cost and Cost Savings Associated With Post-discharge MRSA Decolonization
Medical and non-medical costs of MRSA infection within the 1 year follow up period
Time frame: 1 year
Other Pre-specified
Number of All-cause Infections
Event count of all-cause infections occurring after enrollment
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MRSA Decolonization | Number of All-cause Infections | 207 All-cause infection events |
| Education Arm | Number of All-cause Infections | 252 All-cause infection events |
Other Pre-specified
Number of MRSA Infections
Event count of outpatient and inpatient MRSA infections occurring after enrollment
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MRSA Decolonization | Number of MRSA Infections | 67 MRSA Infection Events |
| Education Arm | Number of MRSA Infections | 98 MRSA Infection Events |
Other Pre-specified
Rehospitalization Due to MRSA Infection
Number of participants experiencing rehospitalization due to MRSA infection (first only)
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MRSA Decolonization | Rehospitalization Due to MRSA Infection | 57 Participants |
| Education Arm | Rehospitalization Due to MRSA Infection | 83 Participants |