Active Bathing to Eliminate Infection (ABATE Infection) Trial

Not Applicable

Completed

• Conditions: Healthcare Associated Infections; Multi Drug Resistant Organisms; Methicillin Resistant Staphylococcus Aureus

• Registration Number: NCT02063867
• Lead Sponsor: University of California, Irvine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-14
• Study Start: 2014-04
• Primary Completion: 2019-02
• Study Completion: 2019-02
• Results First Submitted: 2019-04-29
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-14
• Last Update Submitted: 2019-06-14
• Results First Posted: 2019-07-12
• Last Update Posted: 2019-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
MRSA and VRE Clinical Cultures	21 months	Methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE) clinical cultures attributable to participating units. Defined as occurring \>2 days into a participating unit stay through 2 days following unit discharge

Secondary Outcome Measures

Name	Time	Method
Gram-negative Multi-drug Resistant Organism Clinical Cultures	21 months	Gram-negative (GN) multi-drug resistant organism clinical cultures attributable to participating units. Defined as occurring \>2 days into a participating unit stay through 2 days following unit discharge
All-cause Bloodstream Infections	21 months	All-cause bloodstream infections attributable to participating units. Defined as occurring \>2 days into a participating unit stay through 2 days following unit discharge. Includes bacterial and yeast pathogens. Skin commensals require two positive blood cultures.

Trial Locations

Locations (52)

West Hills Hospital & Medical Center; 🇺🇸 West Hills, California, United States

North Suburban Medical Center; 🇺🇸 Thornton, Colorado, United States

Blake Medical Center; 🇺🇸 Bradenton, Florida, United States

Osceola Regional Medical Center; 🇺🇸 Kissimmee, Florida, United States

Palms West Hospital; 🇺🇸 Loxahatchee Groves, Florida, United States

Orange Park Medical Center; 🇺🇸 Orange Park, Florida, United States

West Florida Hospital; 🇺🇸 Pensacola, Florida, United States

Northside Hospital; 🇺🇸 Saint Petersburg, Florida, United States

St. Petersburg General Hospital; 🇺🇸 Saint Petersburg, Florida, United States

South Bay Hospital; 🇺🇸 Sun City Center, Florida, United States

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