Methicillin-resistant Staphylococcus AureusREDUCE-MRSANCT00980980
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)
A study testing Chlorhexidine bath and nasal mupirocin in people with Methicillin-resistant Staphylococcus Aureus, run by Harvard Pilgrim Health Care at 42 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Methicillin-resistant Staphylococcus Aureus
- What is being tested?
- Chlorhexidine bath and nasal mupirocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74,256 participants
- Where
- 42 sitesUnited States
- Study dates
- Sep 2009to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Inclusion criteria will include all HCA hospitals that reside in US states where physicians do NOT routinely prescribe decolonization for MRSA + ICU patients.
Who cannot join
- 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.
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Alaska Regional
Anchorage, Alaska
The Medical Center of Aurora
Aurora, Colorado
St. David's Medical Center
Austin, Texas
Montgomery Regional Hospital
Blacksburg, Virginia
Blake Medical Center
Brandenton, Florida
Brandon Hospital
Brandon, Florida
Parkridge Medical Center
Chattanooga, Tennessee
Parkland Medical Center
Derry, New Hampshire
Del Sol Medical Center
El Paso, Texas
Las Palmas Medical Center
El Paso, Texas
Columbia Hosp Corp S Broward (Westside)
Fort Lauderdale, Florida
Palms West Hospital
Fort Lauderdale, Florida
Plantation General
Fort Lauderdale, Florida
Garden Park Medical Center
Gulfport, Mississippi
Regional Med Cr Bayonet Point
Hudson, Florida
Eastern Idaho Reg Med Ctr
Idaho Falls, Idaho
Lee's Summit Medical Center
Kansas City, Missouri
Menorah Medical Center
Kansas City, Missouri
Overland Park Regional Hospital
Kansas City, Missouri
Research Belton Hospital
Kansas City, Missouri
Largo Medical Center
Largo, Florida
Moutainview Medical Center
Las Vegas, Nevada
Columbia Alleghany Regional Hospital
Low Moor, Virginia
Coliseum (Macon) Northside
Macon, Georgia
Coliseum Medical Center
Macon, Georgia
Grand Strand Regional Medical Center
Myrtle Beach, South Carolina
Centennial Medical Center
Nashville, Tennessee
Community Hospital
New Port Richey, Florida
Oklahoma University Medical Center
Oklahoma City, Oklahoma
Orange Park Med Ctr
Orange Park, Florida
Medical Center of Plano
Plano, Texas
Fawcett Memorial Hospital
Port Charlotte, Florida
Pulaski Community Hospital
Pulaski, Virginia
Chippenham Johnston Willis
Richmond, Virginia
Methodist Hospital
San Antonio, Texas
Doctors Hospital of Sarasota
Sarasota, Florida
Stonecrest
Smyrna, Tennessee
South Bay Hospital
Sun City Center, Florida
Capital Regional Med Ctr
Tallahassee, Florida
Los Robles Hosp & Med Ctr
Thousand Oaks, California
Cartersville Medical Center
Tucker, Georgia
Clear Lake Regional
Webster, Texas
About this study
Official title: Cluster Randomized Trial of Hospitals to Assess Impact of Targeted Versus Universal
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.
Read the detailed description
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.
- Being tested
- Chlorhexidine bath and nasal mupirocin
- Keywords
- MRSA infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine bath and nasal mupirocinDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| 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+ Receives: Drug: Chlorhexidine bath and nasal mupirocin |
| Arm 3: Universal Decolonization | Active comparator | Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+ Receives: Drug: Chlorhexidine bath and nasal mupirocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (7)
MRSA Bloodstream Infection
Hazard ratio for ICU-attributable MRSA+ blood cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.
Measured: 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.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 25-month time frame represents 7-month baseline and 18-month intervention periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Methicillin-resistant Staphylococcus AureusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Enrolment
- 74,256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Pilgrim Health Care
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Richard Platt, Harvard Pilgrim Health Care
- Investigators
- Richard Platt, MD, MS, Principal investigator, Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare InstituteEdward Septimus, MD, Principal investigator, Hospital Corporation of AmericaSusan Huang, MD MPH, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980980
- Sponsor's protocol ID
- PH000223K
- Other IDs
- HHSA2902005003I, TO #11
- Acronym
- REDUCE-MRSA
- Status last verified
- Mar 2017
- First submitted
- 19 Sep 2009
- Last updated
- 2 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20473200Huang 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.
PubMed 24106942Huang 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.
PubMed 23718152
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomized Trial of Hospitals to Assess Impact of Targeted Versus Universal
- ClinicalTrials.gov ID
- NCT00980980
- Acronym / sponsor ID
- REDUCE-MRSA / PH000223K
- Keywords
- MRSA infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74,256 participants (actual)
- Lead sponsor
- Harvard Pilgrim Health CareUniversity, hospital or other
- 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
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 21 Sep 2009 (estimated)
- Results
- Posted 30 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Usual Care-Active Surveillance | No intervention | –Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+ |
| Arm 2: Targeted Decolonization | Active comparator | Drug: Chlorhexidine bath and nasal mupirocinContinue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+ |
| Arm 3: Universal Decolonization | Active comparator | Drug: Chlorhexidine bath and nasal mupirocinChlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+ |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria will include all HCA hospitals that reside in US states where physicians do NOT routinely prescribe decolonization for MRSA + ICU patients.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine bath and nasal mupirocinThe 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) | Drug | Arm 2: Targeted Decolonization, Arm 3: Universal Decolonization |
Primary outcome
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.
7 secondary outcomes
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.
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.
Intervention Impact on Healthcare Costs
Time frame: 12-month period
Blood Culture Contamination Rates
Time frame: 24-month time frame for this analysis represents a 6-month baseline and 18-month intervention period.
Intervention Impact on Bacteriuria and Candiduria
Time frame: 30-month time frame represents 12-month baseline and 18-month intervention periods.
Intervention Impact on Mupirocin Susceptibility of MRSA Isolates
Time frame: 25-month time frame represents 7-month baseline and 18-month intervention periods
Intervention Impact on Chlorhexidine Susceptibility of MRSA Isolates
Time frame: 25-month time frame represents 7-month baseline and 18-month intervention periods
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20473200Platt 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.
- Background: PubMed 24106942Huang 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.
- Results publication: PubMed 23718152Huang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Platt, MD, MS principal investigator
Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare Institute
Edward Septimus, MD principal investigator
Hospital Corporation of America
Susan Huang, MD MPH principal investigator
University of California, Irvine
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine bath and nasal mupirocin in people with Methicillin-resistant Staphylococcus Aureus, run by Harvard Pilgrim Health Care at 42 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00980980, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.