Overview

This trial is active, not recruiting.

Conditions healthcare associated infections, methicillin resistant staphylococcus aureus, multi drug resistant organisms
Treatment arm 2: decolonization
Sponsor University of California, Irvine
Collaborator Harvard Medical School
Start date April 2014
End date December 2017
Trial size 53 participants
Trial identifier NCT02063867, 367981

Summary

The ABATE Infection Project is a cluster randomized trial of hospitals to compare two quality improvement strategies to reduce multi-drug resistant organisms and healthcare-associated infections in non-critical care units. The two strategies to be evaluated are:

- Arm 1: Routine Care Routine policy for showering/bathing

- Arm 2: Decolonization Use of chlorhexidine as routine soap for showering or bed bathing for all patients Mupirocin x 5 days if MRSA+ by history, culture, or screen

Note that enrolled "subjects" represents 53 individual HCA Hospitals (representing ~190 non-critical care units) that have been randomized.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(No Intervention)
Routine policy for showering or bathing non-critical care patients
(Active Comparator)
Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients. Topical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.
arm 2: decolonization
Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients. Topical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.

Primary Outcomes

Measure
MRSA and VRE clinical cultures
time frame: 18 months

Secondary Outcomes

Measure
Gram-negative multi-drug resistant organism clinical cultures
time frame: 18 months
All-cause bloodstream infections
time frame: 18 months

Eligibility Criteria

Male or female participants at least 12 years old.

Inclusion Criteria: - All HCA hospitals that reside in the United States - Note: Unit of randomization is the hospital, but the participants are hospital units Exclusion Criteria: - Non-critical care units where chlorhexidine bathing or decolonization for MRSA+ non-critical care patients is routine - Pediatric, peri-partum, rehabilitation, psychiatry, and BMT units - Units with >30% cardiac or hip/knee orthopedic surgeries - Unit average length of stay <2 days - Patients <12 years-old - Patients with known allergy to mupirocin or chlorhexidine

Additional Information

Official title Cluster-Randomized Controlled Trial of Hospitals to Reduce Healthcare-Associated Infections and Readmissions Through Routine Bathing With Antiseptic Soap and Targeted Use of Nasal Antibiotic Ointment (ABATE Infection Trial)
Principal investigator Susan Huang, MD MPH
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of California, Irvine.