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| ID | Type | Description | Link |
|---|---|---|---|
| HHSA2902005003I | |||
| TO #11 |
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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
| Centers for Disease Control and Prevention | FED |
| Hospital Corporation of America | INDUSTRY |
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The Randomized Evaluation of Decolonization versus Universal Clearance to Eliminate MRSA (REDUCE MRSA) Trial is a cluster randomized trial of the comparative effectiveness of three strategies to prevent methicillin-resistant Staphylococcus aureus (MRSA) in intensive care units. The three strategies to be evaluated are:
The study is a partnership between the CDC, the CDC Prevention Epicenters, and the Hospital Corporation of America.
Baseline data involving 12 months of data for participating hospitals (July 2008 - June 2009) was collected prior to randomization to account for size and ICU baseline prevalence of MRSA in randomization scheme. Randomization occurred at the hospital level.
Eligibility survey was conducted to determine exclusion criteria.
As of May 2010, enrollment has been closed. 45 hospitals were randomized, but two were found to meet exclusion criteria and were excluded. As-randomized (or as-assigned) analysis included 43 hospitals, representing 74 ICUs. Individual (patient-level) subject enrollment during intervention is 74,256.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Usual Care-Active Surveillance | No Intervention | Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+ | |
| Arm 2: Targeted Decolonization | Active Comparator | Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+ |
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| Arm 3: Universal Decolonization | Active Comparator | Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+ |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine bath and nasal mupirocin | Drug | The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily) |
| Measure | Description | Time Frame |
|---|---|---|
| Main Outcome: Patients With Nosocomial MRSA Clinical Cultures | Hazard ratio for ICU-attributable MRSA+ clinical cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital. | The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| MRSA Bloodstream Infection | Hazard ratio for ICU-attributable MRSA+ blood cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital. | The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Platt, MD, MS | Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare Institute | Principal Investigator |
| Edward Septimus, MD | Hospital Corporation of America | Principal Investigator |
| Susan Huang, MD MPH | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alaska Regional | Anchorage | Alaska | United States | |||
| Los Robles Hosp & Med Ctr |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20473200 | Background | Platt R, Takvorian SU, Septimus E, Hickok J, Moody J, Perlin J, Jernigan JA, Kleinman K, Huang SS. Cluster randomized trials in comparative effectiveness research: randomizing hospitals to test methods for prevention of healthcare-associated infections. Med Care. 2010 Jun;48(6 Suppl):S52-7. doi: 10.1097/MLR.0b013e3181dbebcf. | |
| 24106942 |
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74,256 patients were involved in the intervention period among adult ICUs from the 43 participating hospitals. Routinely collected information for about 48,390 individuals cared for during the baseline period was used for comparison to the experience of the patients in all three arms of the Intervention period.
45 out of 165 Hospital Corporation of America (HCA) hospitals were recruited for this trial of adult ICUs. There was a 12-month baseline period from January 1 through December 31, 2009; a phase-in period from January 1 through April 7, 2010; and an 18-month intervention period from April 8, 2010 through September 30, 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Usual Care-Active Surveillance | Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+ |
| FG001 | Arm 2: Targeted Decolonization | Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+ Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| University of California, Irvine |
| OTHER |
| Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare Institute | UNKNOWN |
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|
| ICU-attributable All-pathogen Bloodstream Infection | Hazard ratio for ICU-attributable positive blood culture from any pathogen, comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital. | The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge. |
| Intervention Impact on Healthcare Costs | Costs (in dollars) per 1000 ICU-admissions associated with 3 ICU strategies to reduce ICU Bloodstream infection (BSI), (Arms 1-3). | 12-month period |
| Blood Culture Contamination Rates | Odds ratio for ICU-attributable blood culture contamination rates, comparing Baseline to Intervention period across Arms, accounting for clustering by hospital. | 24-month time frame for this analysis represents a 6-month baseline and 18-month intervention period. |
| Intervention Impact on Bacteriuria and Candiduria | Proportional hazard ratio for as-randomized, unadjusted, ICU-attributable bacteriuria, comparing Baseline to Intervention period across Arms, accounting for clustering by hospital. High-level bacteriuria is defined as ≥50,000 CFU/mL, high-level candiduria is defined as ≥50,000 CFU/mL. | 30-month time frame represents 12-month baseline and 18-month intervention periods. |
| Intervention Impact on Mupirocin Susceptibility of MRSA Isolates | Odds ratio for MRSA+ isolates from ICU patients expressing low-level mupirocin resistance (LLMR) and high-level mupirocin resistance (HLMR), comparing baseline to intervention period across arms, accounting for clustering by hospital. | 25-month time frame represents 7-month baseline and 18-month intervention periods |
| Intervention Impact on Chlorhexidine Susceptibility of MRSA Isolates | Frequency of MRSA+ isolates from ICU patients with reduced susceptibility to chlorhexidine (CHG) (MIC >4 μg/ml), comparing baseline to intervention period across arms, accounting for clustering by hospital. | 25-month time frame represents 7-month baseline and 18-month intervention periods |
| Thousand Oaks |
| California |
| United States |
| The Medical Center of Aurora | Aurora | Colorado | United States |
| Blake Medical Center | Brandenton | Florida | United States |
| Brandon Hospital | Brandon | Florida | United States |
| Columbia Hosp Corp S Broward (Westside) | Fort Lauderdale | Florida | United States |
| Palms West Hospital | Fort Lauderdale | Florida | United States |
| Plantation General | Fort Lauderdale | Florida | United States |
| Regional Med Cr Bayonet Point | Hudson | Florida | United States |
| Largo Medical Center | Largo | Florida | United States |
| Community Hospital | New Port Richey | Florida | United States |
| Orange Park Med Ctr | Orange Park | Florida | United States |
| Fawcett Memorial Hospital | Port Charlotte | Florida | United States |
| Doctors Hospital of Sarasota | Sarasota | Florida | United States |
| South Bay Hospital | Sun City Center | Florida | United States |
| Capital Regional Med Ctr | Tallahassee | Florida | United States |
| Coliseum (Macon) Northside | Macon | Georgia | United States |
| Coliseum Medical Center | Macon | Georgia | United States |
| Cartersville Medical Center | Tucker | Georgia | United States |
| Eastern Idaho Reg Med Ctr | Idaho Falls | Idaho | United States |
| Garden Park Medical Center | Gulfport | Mississippi | United States |
| Lee's Summit Medical Center | Kansas City | Missouri | United States |
| Menorah Medical Center | Kansas City | Missouri | United States |
| Overland Park Regional Hospital | Kansas City | Missouri | United States |
| Research Belton Hospital | Kansas City | Missouri | United States |
| Moutainview Medical Center | Las Vegas | Nevada | United States |
| Parkland Medical Center | Derry | New Hampshire | United States |
| Oklahoma University Medical Center | Oklahoma City | Oklahoma | United States |
| Grand Strand Regional Medical Center | Myrtle Beach | South Carolina | United States |
| Parkridge Medical Center | Chattanooga | Tennessee | United States |
| Centennial Medical Center | Nashville | Tennessee | United States |
| Stonecrest | Smyrna | Tennessee | United States |
| St. David's Medical Center | Austin | Texas | United States |
| Del Sol Medical Center | El Paso | Texas | United States |
| Las Palmas Medical Center | El Paso | Texas | United States |
| Medical Center of Plano | Plano | Texas | United States |
| Methodist Hospital | San Antonio | Texas | United States |
| Clear Lake Regional | Webster | Texas | United States |
| Montgomery Regional Hospital | Blacksburg | Virginia | United States |
| Columbia Alleghany Regional Hospital | Low Moor | Virginia | United States |
| Pulaski Community Hospital | Pulaski | Virginia | United States |
| Chippenham Johnston Willis | Richmond | Virginia | United States |
| Huang SS, Septimus E, Platt R. Targeted decolonization to prevent ICU infections. N Engl J Med. 2013 Oct 10;369(15):1470-1. doi: 10.1056/NEJMc1309704. No abstract available. |
| 23718152 | Result | Huang SS, Septimus E, Kleinman K, Moody J, Hickok J, Avery TR, Lankiewicz J, Gombosev A, Terpstra L, Hartford F, Hayden MK, Jernigan JA, Weinstein RA, Fraser VJ, Haffenreffer K, Cui E, Kaganov RE, Lolans K, Perlin JB, Platt R; CDC Prevention Epicenters Program; AHRQ DECIDE Network and Healthcare-Associated Infections Program. Targeted versus universal decolonization to prevent ICU infection. N Engl J Med. 2013 Jun 13;368(24):2255-65. doi: 10.1056/NEJMoa1207290. Epub 2013 May 29. |
| FG002 | Arm 3: Universal Decolonization | Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+ Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily) |
| COMPLETED |
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| NOT COMPLETED |
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'Number of Participant' totals reflect total Baseline and Intervention participants combined. 45 hospitals were randomized to a study group, 2 dropped due to exclusion criteria, 43 began the assigned intervention. 1 hospital withdrew during the intervention and was included in as-assigned analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Usual Care-Active Surveillance | Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+ |
| BG001 | Arm 2: Targeted Decolonization | Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+ Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily) |
| BG002 | Arm 3: Universal Decolonization | Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+ Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | Years |
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| Sex/Gender, Customized | Proportion of female study participants, during baseline and intervention study phases. | Number | participants |
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| Overall Number of Participants, by Phase | This table reflects number of admissions with an ICU stay during the Baseline and Intervention periods, separately. Please note that the table above, "Overall Number of Baseline Participants" reflects the total number of participants for which baseline characteristics were measured, across Baseline and Intervention phases combined. | Number | Admissions |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Main Outcome: Patients With Nosocomial MRSA Clinical Cultures | Hazard ratio for ICU-attributable MRSA+ clinical cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital. | The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm. | Posted | Number | 95% Confidence Interval | hazard ratio | The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge. |
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| Secondary | MRSA Bloodstream Infection | Hazard ratio for ICU-attributable MRSA+ blood cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital. | The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm. | Posted | Number | 95% Confidence Interval | hazard ratio | The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge. |
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| Secondary | ICU-attributable All-pathogen Bloodstream Infection | Hazard ratio for ICU-attributable positive blood culture from any pathogen, comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital. | The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm. | Posted | Number | 95% Confidence Interval | Hazard ratio | The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge. |
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| Secondary | Intervention Impact on Healthcare Costs | Costs (in dollars) per 1000 ICU-admissions associated with 3 ICU strategies to reduce ICU Bloodstream infection (BSI), (Arms 1-3). | Annual adult ICU admissions per hospital, over the course of 1 year. | Posted | Number | Dollars per 1000 ICU-admissions | 12-month period |
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| Secondary | Blood Culture Contamination Rates | Odds ratio for ICU-attributable blood culture contamination rates, comparing Baseline to Intervention period across Arms, accounting for clustering by hospital. | The number of participants analyzed reflects the combined total of baseline and intervention admissions, with an ICU stay and a blood draw set, for each arm. | Posted | Number | 95% Confidence Interval | Odds Ratio | 24-month time frame for this analysis represents a 6-month baseline and 18-month intervention period. |
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| Secondary | Intervention Impact on Bacteriuria and Candiduria | Proportional hazard ratio for as-randomized, unadjusted, ICU-attributable bacteriuria, comparing Baseline to Intervention period across Arms, accounting for clustering by hospital. High-level bacteriuria is defined as ≥50,000 CFU/mL, high-level candiduria is defined as ≥50,000 CFU/mL. | The number of participants analyzed reflects the combined total of baseline and intervention admissions with an ICU stay, for each arm. | Posted | Number | 95% Confidence Interval | Hazard Ratio | 30-month time frame represents 12-month baseline and 18-month intervention periods. |
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| Secondary | Intervention Impact on Mupirocin Susceptibility of MRSA Isolates | Odds ratio for MRSA+ isolates from ICU patients expressing low-level mupirocin resistance (LLMR) and high-level mupirocin resistance (HLMR), comparing baseline to intervention period across arms, accounting for clustering by hospital. | The total number of participants analyzed reflects the combined total of baseline and intervention participants during the outcome time frame, for each arm. The total number of units analyzed reflects the combined total of MRSA+ isolates collected from ICU patients during baseline and intervention phase, for each arm. | Posted | Number | 95% Confidence Interval | Odds Ratio | 25-month time frame represents 7-month baseline and 18-month intervention periods | MRSA+ isolates | MRSA+ isolates |
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| Secondary | Intervention Impact on Chlorhexidine Susceptibility of MRSA Isolates | Frequency of MRSA+ isolates from ICU patients with reduced susceptibility to chlorhexidine (CHG) (MIC >4 μg/ml), comparing baseline to intervention period across arms, accounting for clustering by hospital. | The total number of participants analyzed reflects the combined total of baseline and intervention participants during the outcome time frame, for each arm. The total number of units analyzed reflects the combined total of MRSA+ isolates collected from ICU patients during baseline and intervention phase, for each arm. | Posted | Number | MRSA isolates non-susceptible to CHG | 25-month time frame represents 7-month baseline and 18-month intervention periods | MRSA+ isolates | MRSA+ isolates |
|
18 months
Adverse event monitoring and reporting occurred during intervention only, as decolonizing agents were not used during the baseline period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Usual Care-Active Surveillance | Active Surveillance in All Adult ICUs Contact Precautions for MRSA+ | 0 | 23,480 | 0 | 23,480 | ||
| EG001 | Arm 2: Targeted Decolonization | Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+ Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily) | 0 | 24,752 | 2 | 24,752 | ||
| EG002 | Arm 3: Universal Decolonization | Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+ Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily) | 0 | 26,024 | 5 | 26,024 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild | Skin and subcutaneous tissue disorders | Systematic Assessment | A mild adverse event included any criteria less than moderate |
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| Moderate | Skin and subcutaneous tissue disorders | Systematic Assessment | A moderate adverse event included any moderate erythema, scaling or blistering that involves >30% body surface area |
| |
| Severe | Skin and subcutaneous tissue disorders | Systematic Assessment | A severe adverse event included any severe erythema, scaling or blistering that involves >30% body surface area |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Huang | University of California, Irvine | 949-824-5073 | sshuang@uci.edu |
| Intervention Age |
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| Males - Baseline |
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| Females - Intervention |
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| Males - Intervention |
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| Intervention Participants |
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Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
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Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+ Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily) |
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Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
|
| OG002 |
| Arm 3: Universal Decolonization |
Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+ Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily) |
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| Arm 3: Universal Decolonization |
Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+ Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily) |
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