Active Bathing to Eliminate Infection (ABATE Infection) Trial

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Healthcare Associated Infections, Methicillin Resistant Staphylococcus Aureus, Multi Drug Resistant Organisms

Intervention / Treatment
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* Drug: Arm 2: Decolonization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm 1: Usual Care<br>Routine policy for showering or bathing non-critical care patients | |
| Active Comparator: Arm 2: Decolonization<br>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. | Drug: Arm 2: Decolonization<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRSA and VRE Clinical Cultures | 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 | 21 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gram-negative Multi-drug Resistant Organism Clinical Cultures | 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 | 21 months | 
| All-cause Bloodstream Infections | 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. | 21 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HAI, MRSA, VRE