Active Bathing to Eliminate Infection (ABATE Infection) Trial

NCT ID: NCT02063867

Last Updated: 2019-07-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2019-02-28

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.

Detailed Description

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Conditions

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Healthcare Associated Infections Methicillin Resistant Staphylococcus Aureus Multi Drug Resistant Organisms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Arm 1: Usual Care

Routine policy for showering or bathing non-critical care patients

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Arm 2: Decolonization

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role collaborator

Harvard Pilgrim Health Care

OTHER

Sponsor Role collaborator

Hospital Corporation of America

INDUSTRY

Sponsor Role collaborator

Rush University

OTHER

Sponsor Role collaborator

Cook County Health

OTHER_GOV

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Susan Huang

Associate Professor and Medical Director of Epidemiology and Infection Prevention

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan Huang, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Ken Kleinman, ScD

Role: STUDY_DIRECTOR

University of Massachusetts, Amherst

Edward Septimus, MD

Role: STUDY_DIRECTOR

Hospital Corporation of America

Jason Hickok, MBA, RN

Role: STUDY_DIRECTOR

Hospital Corporation of America

Julia Moody, MS

Role: STUDY_DIRECTOR

Hospital Corporation of America

Mary Hayden, MD

Role: STUDY_DIRECTOR

Rush University

Robert Weinstein, MD

Role: STUDY_DIRECTOR

John Stroger Hospital

John Jernigan, MD MS

Role: STUDY_DIRECTOR

Centers for Disease Control and Prevention

Jonathan Perlin, MD PhD

Role: STUDY_DIRECTOR

Hospital Corporation of America

Daniel Gillen, PhD

Role: STUDY_DIRECTOR

University of California, Irvine

Grace Lee, MD MPH

Role: STUDY_DIRECTOR

Harvard Pilgrim Health Care Institute

Locations

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West Hills Hospital & Medical Center

West Hills, California, United States

Site Status

North Suburban Medical Center

Thornton, Colorado, United States

Site Status

Blake Medical Center

Bradenton, Florida, United States

Site Status

Osceola Regional Medical Center

Kissimmee, Florida, United States

Site Status

Palms West Hospital

Loxahatchee Groves, Florida, United States

Site Status

Orange Park Medical Center

Orange Park, Florida, United States

Site Status

West Florida Hospital

Pensacola, Florida, United States

Site Status

Northside Hospital

St. Petersburg, Florida, United States

Site Status

St. Petersburg General Hospital

St. Petersburg, Florida, United States

Site Status

South Bay Hospital

Sun City Center, Florida, United States

Site Status

West Palm Hospital

West Palm Beach, Florida, United States

Site Status

Cartersville Medical Center

Cartersville, Georgia, United States

Site Status

Coliseum Northside Hospital

Macon, Georgia, United States

Site Status

Eastside Medical Center

Snellville, Georgia, United States

Site Status

Overland Park Regional Medical Center

Overland Park, Kansas, United States

Site Status

Regional Medical Center of Acadiana

Lafayette, Louisiana, United States

Site Status

Garden Park Medical Center

Gulfport, Mississippi, United States

Site Status

Research Medical Center

Kansas City, Missouri, United States

Site Status

Lee's Summit Medical Center

Lee's Summit, Missouri, United States

Site Status

Sunrise Hospital and Medical Center

Las Vegas, Nevada, United States

Site Status

MountainView Hospital-Las Vegas

Las Vegas, Nevada, United States

Site Status

Parkland Medical Center

Derry, New Hampshire, United States

Site Status

Portsmouth Regional Hospital

Portsmouth, New Hampshire, United States

Site Status

Colleton Medical Center

Walterboro, South Carolina, United States

Site Status

Parkridge Medical Center

Chattanooga, Tennessee, United States

Site Status

Parkridge East Hospital

Chattanooga, Tennessee, United States

Site Status

TriStar Horizon Medical Center

Dickson, Tennessee, United States

Site Status

Hendersonville Medical Center

Hendersonville, Tennessee, United States

Site Status

Summit Medical Center

Hermitage, Tennessee, United States

Site Status

St. David's Medical Center

Austin, Texas, United States

Site Status

Valley Regional Medical Center

Brownsville, Texas, United States

Site Status

Conroe Regional Medical Center

Conroe, Texas, United States

Site Status

Corpus Christi Medical Center

Corpus Christi, Texas, United States

Site Status

Las Palmas Medical Center

El Paso, Texas, United States

Site Status

Plaza Medical Center of Fort Worth

Fort Worth, Texas, United States

Site Status

Las Colinas Medical Center

Irving, Texas, United States

Site Status

Kingwood Medical Center

Kingwood, Texas, United States

Site Status

Northeast Methodist Hospital

Live Oak, Texas, United States

Site Status

Rio Grande Regional Hospital

McAllen, Texas, United States

Site Status

North Hills Hospital

North Richland Hills, Texas, United States

Site Status

Medical Center of Plano

Plano, Texas, United States

Site Status

Methodist Texsan Hospital

San Antonio, Texas, United States

Site Status

Methodist Hospital

San Antonio, Texas, United States

Site Status

Methodist Specialty and Transplant Hospital

San Antonio, Texas, United States

Site Status

Methodist Stone Oak Hospital

San Antonio, Texas, United States

Site Status

Clear Lake Regional Medical Center

Webster, Texas, United States

Site Status

Timpanogos Regional Hospital

Orem, Utah, United States

Site Status

John Randolph Medical Center

Hopewell, Virginia, United States

Site Status

LewisGale Hospital-Alleghany

Low Moor, Virginia, United States

Site Status

Reston Hospital Center

Reston, Virginia, United States

Site Status

Chippenham Johnston Willis Medical Center

Richmond, Virginia, United States

Site Status

Henrico Doctors' Hospital

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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Huang SS, Septimus E, Kleinman K, Moody J, Hickok J, Heim L, Gombosev A, Avery TR, Haffenreffer K, Shimelman L, Hayden MK, Weinstein RA, Spencer-Smith C, Kaganov RE, Murphy MV, Forehand T, Lankiewicz J, Coady MH, Portillo L, Sarup-Patel J, Jernigan JA, Perlin JB, Platt R; ABATE Infection trial team. Chlorhexidine versus routine bathing to prevent multidrug-resistant organisms and all-cause bloodstream infections in general medical and surgical units (ABATE Infection trial): a cluster-randomised trial. Lancet. 2019 Mar 23;393(10177):1205-1215. doi: 10.1016/S0140-6736(18)32593-5. Epub 2019 Mar 5.

Reference Type DERIVED
PMID: 30850112 (View on PubMed)

Johnson KE, Neta G, Dember LM, Coronado GD, Suls J, Chambers DA, Rundell S, Smith DH, Liu B, Taplin S, Stoney CM, Farrell MM, Glasgow RE. Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. Trials. 2016 Jan 16;17:32. doi: 10.1186/s13063-016-1158-y.

Reference Type DERIVED
PMID: 26772801 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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UH2AT007769

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UH3AI113337

Identifier Type: NIH

Identifier Source: secondary_id

View Link

367981

Identifier Type: -

Identifier Source: org_study_id

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