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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)

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00980980
First received: September 19, 2009
Last updated: August 22, 2016
Last verified: August 2016

September 19, 2009
August 22, 2016
September 2009
September 2011   (final data collection date for 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. ] [ Designated as safety issue: No ]
Hazard ratio for ICU-attributable MRSA+ clinical cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.
Main Outcome: Patients With Nosocomial MRSA Clinical Cultures
Complete list of historical versions of study NCT00980980 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 Chlorhexidine and Mupirocin Susceptibility of MRSA Isolates [ Time Frame: TBD ] [ Designated as safety issue: No ]
  • Nosocomial MRSA Bloodstream and Urinary Cultures
  • Routinely reported central line associated blood stream infections (CLABSI).
Not Provided
Not Provided
 
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)
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.

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.

Interventional
Not Provided
Allocation: Randomized
Primary Purpose: Prevention
Methicillin-resistant Staphylococcus Aureus
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)
  • No Intervention: Arm 1: Usual Care-Active Surveillance
    Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
  • Active Comparator: Arm 2: Targeted Decolonization
    Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
    Intervention: Drug: Chlorhexidine bath and nasal mupirocin
  • Active Comparator: Arm 3: Universal Decolonization
    Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+
    Intervention: Drug: Chlorhexidine bath and nasal mupirocin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74256
September 2011
September 2011   (final data collection date for primary outcome measure)

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.
Both
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00980980
PH000223K, HHSA2902005003I, TO #11
No
Not Provided
Not Provided
Richard Platt, Harvard Pilgrim Health Care
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
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
Harvard Pilgrim Health Care
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP