Healthcare Associated InfectionsABATENCT02063867

Active Bathing to Eliminate Infection (ABATE Infection) Trial

A study testing Arm 2: Decolonization in people with Healthcare Associated Infections and Methicillin Resistant Staphylococcus Aureus, run by University of California, Irvine at 52 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Healthcare Associated Infections, Methicillin Resistant Staphylococcus Aureus, Multi Drug Resistant Organisms
What is being tested?: Arm 2: Decolonization
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 52 sitesUnited States
Study dates: Apr 2014to Feb 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

All HCA hospitals that reside in the United States
Note: Unit of randomization is the hospital, but the participants are hospital units

Who cannot join

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

Trial locations and contacts

52 sites in 1 country.

City, postcode or hospital

52 sites in 1 country

United States52 sites

St. David's Medical Center
Austin, Texas, 78705
Blake Medical Center
Bradenton, Florida, 34209
Valley Regional Medical Center
Brownsville, Texas, 78526
Cartersville Medical Center
Cartersville, Georgia, 30120
Parkridge Medical Center
Chattanooga, Tennessee, 37404
Parkridge East Hospital
Chattanooga, Tennessee, 37412
Conroe Regional Medical Center
Conroe, Texas, 77304
Corpus Christi Medical Center
Corpus Christi, Texas, 78411
Parkland Medical Center
Derry, New Hampshire, 03038
TriStar Horizon Medical Center
Dickson, Tennessee, 37055
Las Palmas Medical Center
El Paso, Texas, 79902
Plaza Medical Center of Fort Worth
Fort Worth, Texas, 76104
Garden Park Medical Center
Gulfport, Mississippi, 39503
Hendersonville Medical Center
Hendersonville, Tennessee, 37075
Summit Medical Center
Hermitage, Tennessee, 37076
John Randolph Medical Center
Hopewell, Virginia, 23860
Las Colinas Medical Center
Irving, Texas, 75039
Research Medical Center
Kansas City, Missouri, 64132
Kingwood Medical Center
Kingwood, Texas, 77339
Osceola Regional Medical Center
Kissimmee, Florida, 34741
Regional Medical Center of Acadiana
Lafayette, Louisiana, 70506
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
MountainView Hospital-Las Vegas
Las Vegas, Nevada, 89128
Lee's Summit Medical Center
Lee's Summit, Missouri, 64063
Northeast Methodist Hospital
Live Oak, Texas, 78233
LewisGale Hospital-Alleghany
Low Moor, Virginia, 24457
Palms West Hospital
Loxahatchee Groves, Florida, 33470
Coliseum Northside Hospital
Macon, Georgia, 31210
Rio Grande Regional Hospital
McAllen, Texas, 78503
North Hills Hospital
North Richland Hills, Texas, 76180
Orange Park Medical Center
Orange Park, Florida, 32073
Timpanogos Regional Hospital
Orem, Utah, 84057
Overland Park Regional Medical Center
Overland Park, Kansas, 66215
West Florida Hospital
Pensacola, Florida, 32514
Medical Center of Plano
Plano, Texas, 75075
Portsmouth Regional Hospital
Portsmouth, New Hampshire, 03801
Reston Hospital Center
Reston, Virginia, 20190
Chippenham Johnston Willis Medical Center
Richmond, Virginia, 23225
Henrico Doctors' Hospital
Richmond, Virginia, 23229
Methodist Texsan Hospital
San Antonio, Texas, 78201
Methodist Hospital
San Antonio, Texas, 78229
Methodist Specialty and Transplant Hospital
San Antonio, Texas, 78229
Methodist Stone Oak Hospital
San Antonio, Texas, 78258
Eastside Medical Center
Snellville, Georgia, 30078
Northside Hospital
St. Petersburg, Florida, 33709
St. Petersburg General Hospital
St. Petersburg, Florida, 33710
South Bay Hospital
Sun City Center, Florida, 33573
North Suburban Medical Center
Thornton, Colorado, 80229
Colleton Medical Center
Walterboro, South Carolina, 29488
Clear Lake Regional Medical Center
Webster, Texas, 77598
West Hills Hospital & Medical Center
West Hills, California, 91307
West Palm Hospital
West Palm Beach, Florida, 33407

Other trials in United States

About this study

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)

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.

Conditions: Healthcare Associated Infections, Methicillin Resistant Staphylococcus Aureus, Multi Drug Resistant Organisms
Being tested: Arm 2: Decolonization
Keywords: HAI, MRSA, VRE
Medical subject headings: Cross Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Arm 2: DecolonizationDrug
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.

Study groups in NCT02063867
Study group	Role	What they receive
Arm 1: Usual Care	No intervention	Routine policy for showering or bathing non-critical care patients
Arm 2: Decolonization	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. Receives: Drug: Arm 2: Decolonization

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 21 months

Secondary outcomes (2)

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
Measured: 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.
Measured: 21 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Feb 2019

First posted14 Feb 2014 (estimated)
Study startApr 2014
Primary completionFeb 2019
Study completionFeb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Healthcare Associated InfectionsStudies of the same condition, open and under way.
More trials run by University of California, IrvineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02063867
Sponsor's protocol ID: 367981
Other IDs: UH2AT007769, UH3AI113337
Acronym: ABATE
Status last verified: Jun 2019
First submitted: 12 Feb 2014
Last updated: 12 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 30850112
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.
PubMed 26772801

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Initial and Subsequent Healthcare-Associated Infections in Intensive Care Patients
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Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
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Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia

All Healthcare Associated Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT02063867
Acronym / sponsor ID: ABATE / 367981
Conditions: Healthcare Associated Infections, Methicillin Resistant Staphylococcus Aureus, Multi Drug Resistant Organisms
Keywords: HAI, MRSA, VRE
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: University of California, IrvineUniversity, hospital or other
Collaborators: Harvard Medical School (HMS and HSDM), Harvard Pilgrim Health Care, Hospital Corporation of America, Rush University, Cook County Health, Centers for Disease Control and Prevention, National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
Study start: Apr 2014
Primary completion: Feb 2019 (actual)
Study completion: Feb 2019 (actual)
First posted: 14 Feb 2014 (estimated)
Results: Posted 12 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm 1: Usual Care	No intervention	–Routine policy for showering or bathing non-critical care patients
Arm 2: Decolonization	Active comparator	Drug: Arm 2: DecolonizationDaily 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.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

All HCA hospitals that reside in the United States
Note: Unit of randomization is the hospital, but the participants are hospital units

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Arm 2: DecolonizationDaily 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

Primary outcome

MRSA and VRE Clinical Cultures
Time frame: 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

2 secondary outcomes

Gram-negative Multi-drug Resistant Organism Clinical Cultures
Time frame: 21 months
All-cause Bloodstream Infections
Time frame: 21 months

Results and safety

Results posted to the registry on 12 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: Usual Care	156,889	152,598
Arm 2: Decolonization	183,013	180,048

Primary outcome: MRSA and VRE Clinical Cultures

Time frame: 21 months. Number (95% Confidence Interval). Unit: Hazard Ratio (Intervention vs Baseline)

Measure	Arm 1: Usual Care n = 156889	Arm 2: Decolonization n = 183013
Value	0.87 (0.79 to 0.95)	0.79 (0.73 to 0.87)

Arm 1: Usual Care vs Arm 2: Decolonization: p = 0.17, Mixed Models Analysis

Population analysed: Unadjusted intention-to-treat analysis. Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Intervention duration (21 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: Usual Care	0 of 156,889 (0%)	0 of 156,889 (0%)	0 of 156,889
Arm 2: Decolonization	0 of 183,013 (0%)	25 of 183,013 (0%)	0 of 183,013

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30850112Huang 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.
Derived from this study: PubMed 26772801Johnson 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.

Related trials for Healthcare Associated Infections

Not yet recruiting
Evaluation of an AI-Assisted Tool for CLABSI Surveillance at VA Medical Centers
Central Line-Associated Bloodstream Infection (CLABSI), Bacteremia
Active, not recruitingObservational study
Initial and Subsequent Healthcare-Associated Infections in Intensive Care Patients
Cross Infection, Intensive Care Units
Enrolling by invitationObservational study
Prospective Healthcare-Associated Links in Transmission of Nontuberculous Mycobacteria
Cystic Fibrosis, Nontuberculous Mycobacterial Pulmonary Infection
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Susan Huang, MD MPH principal investigator

University of California, Irvine

Ken Kleinman, ScD study director

University of Massachusetts, Amherst

Edward Septimus, MD study director

Hospital Corporation of America

52 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRSA and VRE Clinical Cultures (time frame: 21 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02063867, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.