Active Bathing to Eliminate Infection (ABATE Infection) T... | NCT02063867

ID	Type	Description	Link
UH2AT007769	U.S. NIH Grant/Contract		View source
UH3AI113337	U.S. NIH Grant/Contract		View source

Status Module

Sponsor/Collaborators Module

Name	Class
Harvard Medical School (HMS and HSDM)	OTHER
Harvard Pilgrim Health Care	OTHER
Hospital Corporation of America	INDUSTRY
Rush University

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: Arm 2: Decolonization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Arm 2: Decolonization	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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Urinary Tract Infections	Urinary tract infections attributable to participating units. Defined as occurring >2 days into a participating unit stay through 2 days following unit discharge	21 months
Blood Culture Contamination

Eligibility Module

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Susan Huang, MD MPH	University of California, Irvine	Principal Investigator
Ken Kleinman, ScD	University of Massachusetts, Amherst	Study Director
Edward Septimus, MD	Hospital Corporation of America	Study Director
Jason Hickok, MBA, RN	Hospital Corporation of America	Study Director
Julia Moody, MS	Hospital Corporation of America	Study Director
Mary Hayden, MD	Rush University	Study Director
Robert Weinstein, MD	John Stroger Hospital	Study Director
John Jernigan, MD MS	Centers for Disease Control and Prevention	Study Director
Jonathan Perlin, MD PhD	Hospital Corporation of America	Study Director
Daniel Gillen, PhD

Facility	Status	City	State	ZIP	Country	Contacts
West Hills Hospital & Medical Center		West Hills	California	91307	United States
North Suburban Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30850112	Derived	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.
26772801

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Arm 1: Usual Care	Routine policy for showering or bathing non-critical care patients
FG001	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. 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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 30, 2015	May 29, 2019

Arm/Group Information

ID	Title	Description
BG000	Arm 1: Usual Care	Routine policy for showering or bathing non-critical care patients
BG001	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. 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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0000.87(0.79 to 0.95) OG0010.79(0.73 to 0.87)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis	Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals	0.17														Superiority

Secondary

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

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

Posted

Number

95% Confidence Interval

Hazard Ratio (Intervention vs Baseline)

21 months

ID	Title	Description
OG000	Arm 1: Usual Care	Routine policy for showering or bathing non-critical care patients
OG001	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. 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.

Units

Secondary

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.

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

Posted

Number

95% Confidence Interval

Hazard Ratio

21 months

ID	Title	Description
OG000	Arm 1: Usual Care	Routine policy for showering or bathing non-critical care patients
OG001	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. 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.

Units

Other Pre-specified

Urinary Tract Infections

Urinary tract infections attributable to participating units. Defined as occurring >2 days into a participating unit stay through 2 days following unit discharge

Not Posted

21 months

Participants

Other Pre-specified

Blood Culture Contamination

Blood culture contamination

Not Posted

21 months

Participants

Other Pre-specified

Clostridium Difficile Infection

Clostridium difficile Infection attributable to participating units

Not Posted

21 months

Participants

Other Pre-specified

30-Day Infectious Readmissions

30-Day Infectious Readmissions among patients in participating units

Not Posted

21 months

Participants

Other Pre-specified

Emergence of Resistance to Chlorhexidine or Mupirocin

Emergence of resistance to chlorhexidine (among MRSA and select gram-negative bacteria) or mupirocin (among MRSA) for strains isolated from participating units

Not Posted

21 months

Participants

Other Pre-specified

Cost Effectiveness

Cost effectiveness of routine care vs decolonization

Not Posted

21 months

Participants

Post-Hoc

MRSA and VRE Clinical Cultures Among Patients With Devices

Sub-population analysis: 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), among patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains).

Unadjusted intention-to-treat analysis of sub-population: patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains). Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)

Posted

Number

95% Confidence Interval

Hazard Ratio

21 months

ID	Title	Description
OG000	Arm 1: Usual Care	Routine policy for showering or bathing non-critical care patients
OG001	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. 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.

Post-Hoc

MRSA Clinical Cultures Among Patients With Devices

Sub-population analysis: Methicillin-resistant Staphylococcus aureus (MRSA) clinical cultures attributable to participating units (defined as occurring >2 days into a participating unit stay through 2 days following unit discharge), among patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains).

Posted

Number

95% Confidence Interval

Hazard Ratio

21 months

ID	Title	Description
OG000	Arm 1: Usual Care	Routine policy for showering or bathing non-critical care patients
OG001	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. 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.

Post-Hoc

VRE Clinical Cultures Among Patients With Devices

Sub-population analysis: 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), among patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains).

Posted

Number

95% Confidence Interval

Hazard Ratio

21 months

ID	Title	Description
OG000	Arm 1: Usual Care	Routine policy for showering or bathing non-critical care patients
OG001	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. 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.

Post-Hoc

All-cause Bloodstream Infections Among Patients With Devices

Sub-population analysis: All-cause bloodstream infections attributable to participating units (defined as occurring >2 days into a participating unit stay through 2 days following unit discharge), among patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains). Includes bacterial and yeast pathogens. Skin commensals require two positive blood cultures.

Posted

Number

95% Confidence Interval

Hazard Ratio

21 months

ID	Title	Description
OG000	Arm 1: Usual Care	Routine policy for showering or bathing non-critical care patients
OG001	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. 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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm 1: Usual Care	Routine policy for showering or bathing non-critical care patients	0	156,889	0	156,889	0	156,889
EG001	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. 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.	0	183,013	0	183,013	25	183,013

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Diffuse rash	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected156,889 at risk EG0015 events5 affected183,013 at risk
Diffuse itching	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected156,889 at risk EG0011 events1 affected183,013 at risk
Mild rash on trunk	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected156,889 at risk EG0014 events4 affected183,013 at risk
Mild rash, location unknown	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected156,889 at risk EG0011 events1 affected183,013 at risk
Mild rash on limbs	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected156,889 at risk EG0012 events2 affected183,013 at risk
Mild rash on limbs, trunk	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected156,889 at risk EG0016 events6 affected183,013 at risk
Mild rash on groin	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected156,889 at risk EG0011 events1 affected183,013 at risk
Mild rash on limbs, face	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected156,889 at risk EG0011 events1 affected183,013 at risk
Mild rash on limbs, groin	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected156,889 at risk EG0011 events1 affected183,013 at risk
Mild rash on limbs, trunk, face	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected156,889 at risk EG0011 events1 affected183,013 at risk
Mild rash on limbs, trunk, groin	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected156,889 at risk EG0011 events1 affected183,013 at risk
Mild rash on neck, forehead	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected156,889 at risk EG0011 events1 affected183,013 at risk

ID	Term
D007239	Infections
D007049	Iatrogenic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms