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)

Methicillin-resistant Staphylococcus Aureus Clinical Trial

— REDUCE-MRSA  

Official title:

Cluster Randomized Trial of Hospitals to Assess Impact of Targeted Versus Universal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00980980
• Other study ID #: PH000223K
• Secondary ID: HHSA2902005003IT
• Status: Completed
• Phase: N/A
• First received: September 19, 2009
• Last updated: August 18, 2014
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: August 2014
• Source: Harvard Pilgrim Health Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74256
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Methicillin-resistant Staphylococcus Aureus
• Staphylococcal Infections

Intervention

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)

Locations

Country	Name	City	State
United States	Alaska Regional	Anchorage	Alaska
United States	The Medical Center of Aurora	Aurora	Colorado
United States	St. David's Medical Center	Austin	Texas
United States	Montgomery Regional Hospital	Blacksburg	Virginia
United States	Blake Medical Center	Brandenton	Florida
United States	Brandon Hospital	Brandon	Florida
United States	Parkridge Medical Center	Chattanooga	Tennessee
United States	Parkland Medical Center	Derry	New Hampshire
United States	Del Sol Medical Center	El Paso	Texas
United States	Las Palmas Medical Center	El Paso	Texas
United States	Columbia Hosp Corp S Broward (Westside)	Ft. Lauderdale	Florida
United States	Palms West Hospital	Ft. Lauderdale	Florida
United States	Plantation General	Ft. Lauderdale	Florida
United States	Garden Park Medical Center	Gulfport	Mississippi
United States	Regional Med Cr Bayonet Point	Hudson	Florida
United States	Eastern Idaho Reg Med Ctr	Idaho Falls	Idaho
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	Largo Medical Center	Largo	Florida
United States	Moutainview Medical Center	Las Vegas	Nevada
United States	Columbia Alleghany Regional Hospital	LowMoor	Virginia
United States	Coliseum (Macon) Northside	Macon	Georgia
United States	Coliseum Medical Center	Macon	Georgia
United States	Grand Strand Regional Medical Center	Myrtle Beach	South Carolina
United States	Centennial Medical Center	Nashville	Tennessee
United States	Community Hospital	New Port Richey	Florida
United States	Oklahoma University Medical Center	Oklahoma City	Oklahoma
United States	Orange Park Med Ctr	Orange Park	Florida
United States	Medical Center of Plano	Plano	Texas
United States	Fawcett Memorial Hospital	Port Charlotte	Florida
United States	Pulaski Community Hospital	Pulaski	Virginia
United States	Chippenham Johnston Willis	Richmond	Virginia
United States	Methodist Hospital	San Antonio	Texas
United States	Doctors Hospital of Sarasota	Sarasota	Florida
United States	Stonecrest	Smyrna	Tennessee
United States	South Bay Hospital	Sun City Center	Florida
United States	Capital Regional Med Ctr	Tallahassee	Florida
United States	Los Robles Hosp & Med Ctr	Thousand Oaks	California
United States	Cartersville Medical Center	Tucker	Georgia
United States	Clear Lake Regional	Webster	Texas

Sponsors (6)

Lead Sponsor	Collaborator
Harvard Pilgrim Health Care	Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention, Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare Institute, Hospital Corporation of America, University of California, Irvine

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 Pr — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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 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.	No
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 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.	No
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 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.	No
Secondary	Urinary Tract Infections		18-months	No
Secondary	Emergence of Resistance to Mupirocin and Chlorhexidine		18-months	No
Secondary	Cost Effectiveness		18-months	No
Secondary	Blood Culture Contamination		18-months	No

External Links

•   AHRQ Toolkit: Universal ICU Decolonization: An Enhanced Protocol
•   NEJM Study Results Publication
•   Platt R, Huang SS, Perlin JB. A win for the learning health system. Commentary Series of the IOM Roundable on Value & Science-Driven Health Care. Institute of Medicine of the National Academies of Sciences. May 29, 2013