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 CulturesRoutinely 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
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