Cluster Randomized Trial of Hospitals to Assess Impact of Targeted Versus Universal Strategies to Reduce Methicillin-resistant Staphylococcus Aureus (MRSA) in Intensive Care Units (ICUs) (REDUCE-MRSA)
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| ClinicalTrials.gov Identifier: NCT00980980 |
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Recruitment Status :
Completed
First Posted : September 21, 2009
Results First Posted : July 30, 2014
Last Update Posted : May 2, 2017
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Sponsor:
Harvard Pilgrim Health Care
Collaborators:
Agency for Healthcare Research and Quality (AHRQ)
Centers for Disease Control and Prevention
Hospital Corporation of America
University of California, Irvine
Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare Institute
Information provided by (Responsible Party):
Richard Platt, Harvard Pilgrim Health Care
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Brief Summary:
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:
- screening on admission followed by isolation of MRSA+ patients
- screening on admission followed by isolation and decolonization of MRSA+ patients
- universal decolonization on admission with no screening. The decolonization regimen involves bathing with chlorhexidine plus intra-nasal application of mupirocin. The main outcome will be MRSA+ clinical cultures.
The study is a partnership between the CDC, the CDC Prevention Epicenters, and the Hospital Corporation of America.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Methicillin-resistant Staphylococcus Aureus | Drug: Chlorhexidine bath and nasal mupirocin | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 74256 participants |
| Allocation: | Randomized |
| Primary Purpose: | Prevention |
| Official Title: | Cluster Randomized Trial of Hospitals to Assess Impact of Targeted Versus Universal |
| Study Start Date : | September 2009 |
| Actual Primary Completion Date : | September 2011 |
| Actual Study Completion Date : | September 2011 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
MRSA
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Arm 1: Usual Care-Active Surveillance
Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
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Active Comparator: Arm 2: Targeted Decolonization
Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
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Drug: 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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Active Comparator: Arm 3: Universal Decolonization
Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+
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Drug: 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) |
Primary Outcome Measures :
- Main Outcome: Patients With Nosocomial MRSA Clinical Cultures [ Time Frame: 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. ]Hazard ratio for ICU-attributable MRSA+ clinical cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.
Secondary Outcome Measures :
- MRSA Bloodstream Infection [ Time Frame: 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. ]Hazard ratio for ICU-attributable MRSA+ blood cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.
- ICU-attributable All-pathogen Bloodstream Infection [ Time Frame: 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. ]Hazard ratio for ICU-attributable positive blood culture from any pathogen, comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.
- Intervention Impact on Healthcare Costs [ Time Frame: 12-month period ]Costs (in dollars) per 1000 ICU-admissions associated with 3 ICU strategies to reduce ICU Bloodstream infection (BSI), (Arms 1-3).
- Blood Culture Contamination Rates [ Time Frame: 24-month time frame for this analysis represents a 6-month baseline and 18-month intervention period. ]Odds ratio for ICU-attributable blood culture contamination rates, comparing Baseline to Intervention period across Arms, accounting for clustering by hospital.
- Intervention Impact on Bacteriuria and Candiduria [ Time Frame: 30-month time frame represents 12-month baseline and 18-month intervention periods. ]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.
- Intervention Impact on Mupirocin Susceptibility of MRSA Isolates [ Time Frame: 25-month time frame represents 7-month baseline and 18-month intervention periods ]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.
- Intervention Impact on Chlorhexidine Susceptibility of MRSA Isolates [ Time Frame: 25-month time frame represents 7-month baseline and 18-month intervention periods ]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.
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| Ages Eligible for Study: | 13 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Inclusion criteria will include all HCA hospitals that reside in US states where physicians do NOT routinely prescribe decolonization for MRSA + ICU patients.
Exclusion Criteria:
- Exclusion criteria will include hospitals where ICU physicians often prescribe decolonization for MRSA+ ICU patients.
- Dedicated burn ICUs will also be excluded due to the inability to perform routine bathing.
- Finally, since the intent is to assess the intervention in adult ICUs, pediatric hospitals will be excluded although patients <13 years old that are admitted to participating adult ICUs will be included in the unit-based intervention.
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): NCT00980980
Locations
Show 42 study locations
Sponsors and Collaborators
Harvard Pilgrim Health Care
Agency for Healthcare Research and Quality (AHRQ)
Centers for Disease Control and Prevention
Hospital Corporation of America
University of California, Irvine
Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare Institute
Investigators
| Principal Investigator: | Richard Platt, MD, MS | Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare Institute | |
| Principal Investigator: | Edward Septimus, MD | Hospital Corporation of America (HCA) | |
| Principal Investigator: | Susan Huang, MD MPH | University of California, Irvine |
Additional Information:
Publications of Results:
Other Publications:
Publications of Results:
Other Publications:
| Responsible Party: | Richard Platt, Professor and Department Chair, Harvard Pilgrim Health Care |
| ClinicalTrials.gov Identifier: | NCT00980980 |
| Other Study ID Numbers: |
PH000223K HHSA2902005003I TO #11 |
| First Posted: | September 21, 2009 Key Record Dates |
| Results First Posted: | July 30, 2014 |
| Last Update Posted: | May 2, 2017 |
| Last Verified: | March 2017 |
Keywords provided by Richard Platt, Harvard Pilgrim Health Care:
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MRSA infection |
Additional relevant MeSH terms:
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Staphylococcal Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections Chlorhexidine Mupirocin |
Anti-Infective Agents, Local Anti-Infective Agents Disinfectants Anti-Bacterial Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |