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)

Harvard Pilgrim Health Care

Status: Completed

Conditions: Methicillin-resistant Staphylococcus Aureus

Treatments: Drug: Chlorhexidine bath and nasal mupirocin

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00980980

TO #11

HHSA2902005003I

PH000223K

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74,256 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

74,256 participants in 3 patient groups

Arm 1: Usual Care-Active Surveillance

No Intervention group

Description:

Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+

Arm 2: Targeted Decolonization

Active Comparator group

Description:

Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+

Treatment:

Drug: Chlorhexidine bath and nasal mupirocin

Arm 3: Universal Decolonization

Active Comparator group

Description:

Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+

Treatment:

Drug: Chlorhexidine bath and nasal mupirocin