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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)

Information source: Harvard Pilgrim Health Care
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: MRSA Infection; Methicillin-resistant Staphylococcus Aureus

Intervention: Chlorhexidine bath and nasal mupirocin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Harvard Pilgrim Health Care

Official(s) and/or principal investigator(s):
Richard Platt, MD, MS, Principal Investigator, Affiliation: Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare Institute
Edward Septimus, MD, Principal Investigator, Affiliation: Hospital Corporation of America (HCA)
Susan Huang, MD MPH, Principal Investigator, Affiliation: University of California, Irvine

Overall contact:
Julie Dunn, MPH, Phone: 617-509-9880, Email: Julie_Dunn@hphc.org

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. Approximately 60 hospitals will be randomized. The study is a partnership between the CDC, the CDC Prevention Epicenters, and the Hospital Corporation of America.

Clinical Details

Official title: Cluster Randomized Trial of Hospitals to Assess Impact of Targeted Versus Universal

Study design: Health Services Research, Randomized

Primary outcome: Main Outcome: Patients with Nosocomial MRSA Clinical Cultures

Secondary outcome:

Nosocomial MRSA Bloodstream and Urinary Cultures

Routinely reported central line associated blood stream infections (CLABSI).

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Julie Dunn, MPH, Phone: 617-509-9880, Email: Julie_Dunn@hphc.org

Department of Population Medicine, Harvard Medical School Harvard Pilgrim Healthcare Institute, Boston, Massachusetts 02215, United States; Recruiting
Richard Platt, MD MS, Principal Investigator
Additional Information

Starting date: September 2009
Last updated: September 22, 2009

Page last updated: October 19, 2009

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