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Trial record 1 of 1 for:    NCT02063867
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Active Bathing to Eliminate Infection (ABATE Infection) Trial (ABATE)

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ClinicalTrials.gov Identifier: NCT02063867
Recruitment Status : Completed
First Posted : February 14, 2014
Results First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborators:
Harvard Medical School
Harvard Pilgrim Health Care
Hospital Corporation of America (HCA)
Rush University
John H. Stroger Hospital
Centers for Disease Control and Prevention
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Susan Huang, University of California, Irvine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions Healthcare Associated Infections
Methicillin Resistant Staphylococcus Aureus
Multi Drug Resistant Organisms
Intervention Drug: Arm 2: Decolonization
Enrollment 53
Recruitment Details The Participant Flow section reflects numbers of hospitals that were enrolled in the intervention (the unit of enrollment and randomization was hospital), as well as the number of participants included in analysis, (the number of patient admissions from participating units in the enrolled hospitals), in each arm during the intervention period.
Pre-assignment Details  
Arm/Group Title Arm 1: Usual Care Arm 2: Decolonization
Hide Arm/Group Description Routine policy for showering or bathing non-critical care patients

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.

Period Title: Overall Study
Number of participants Number of units (hospitals) Number of participants Number of units (hospitals)
Started 156889 26 183013 27
Completed 152598 24 180048 24
Not Completed 4291 2 2965 3
Arm/Group Title Arm 1: Usual Care Arm 2: Decolonization Total
Hide Arm/Group Description Routine policy for showering or bathing non-critical care patients

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.

Total of all reporting groups
Overall Number of Baseline Participants 156889 183013 339902
Hide Baseline Analysis Population Description
These numbers reflect the number of participants in the baseline period across all participating facilities enrolled.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 156889 participants 183013 participants 339902 participants
62.3  (18.2) 62.6  (18.6) 62.4  (18.4)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156873 participants 182997 participants 339870 participants
Female
84585
  53.9%
100249
  54.8%
184834
  54.4%
Male
72288
  46.1%
82748
  45.2%
155036
  45.6%
[1]
Measure Analysis Population Description: Data not available for 32 patients during the intervention period.
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 156889 participants 183013 participants 339902 participants
107261
  68.4%
112067
  61.2%
219328
  64.5%
Hispanic Number Analyzed 156889 participants 183013 participants 339902 participants
22581
  14.4%
38704
  21.1%
61285
  18.0%
Black Number Analyzed 156889 participants 183013 participants 339902 participants
21501
  13.7%
22462
  12.3%
43963
  12.9%
Asian Number Analyzed 156889 participants 183013 participants 339902 participants
2021
   1.3%
4175
   2.3%
6196
   1.8%
Other/Unknown Number Analyzed 156889 participants 183013 participants 339902 participants
3525
   2.2%
5605
   3.1%
9130
   2.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 156889 participants 183013 participants 339902 participants
156889 183013 339902
1.Primary Outcome
Title MRSA and VRE Clinical Cultures
Hide Description 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
Time Frame 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
Unadjusted intention-to-treat analysis. Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)
Arm/Group Title Arm 1: Usual Care Arm 2: Decolonization
Hide Arm/Group Description:
Routine policy for showering or bathing non-critical care patients

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.

Overall Number of Participants Analyzed 156889 183013
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Hazard Ratio (Intervention vs Baseline)
0.87
(0.79 to 0.95)
0.79
(0.73 to 0.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Usual Care, Arm 2: Decolonization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Mixed Models Analysis
Comments Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals
2.Secondary Outcome
Title Gram-negative Multi-drug Resistant Organism Clinical Cultures
Hide Description 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
Time Frame 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
Unadjusted intention-to-treat analysis. Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)
Arm/Group Title Arm 1: Usual Care Arm 2: Decolonization
Hide Arm/Group Description:
Routine policy for showering or bathing non-critical care patients

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.

Overall Number of Participants Analyzed 156889 183013
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Hazard Ratio (Intervention vs Baseline)
0.81
(0.72 to 0.91)
0.91
(0.82 to 1.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Usual Care, Arm 2: Decolonization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Mixed Models Analysis
Comments Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals
3.Secondary Outcome
Title All-cause Bloodstream Infections
Hide Description 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.
Time Frame 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
Unadjusted intention-to-treat analysis. Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)
Arm/Group Title Arm 1: Usual Care Arm 2: Decolonization
Hide Arm/Group Description:
Routine policy for showering or bathing non-critical care patients

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.

Overall Number of Participants Analyzed 156889 183013
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Hazard Ratio
0.96
(0.85 to 1.08)
0.90
(0.80 to 1.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Usual Care, Arm 2: Decolonization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method Mixed Models Analysis
Comments Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals
4.Other Pre-specified Outcome
Title Urinary Tract Infections
Hide Description Urinary tract infections attributable to participating units. Defined as occurring >2 days into a participating unit stay through 2 days following unit discharge
Time Frame 21 months
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title Blood Culture Contamination
Hide Description Blood culture contamination
Time Frame 21 months
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Clostridium Difficile Infection
Hide Description Clostridium difficile Infection attributable to participating units
Time Frame 21 months
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title 30-Day Infectious Readmissions
Hide Description 30-Day Infectious Readmissions among patients in participating units
Time Frame 21 months
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Emergence of Resistance to Chlorhexidine or Mupirocin
Hide Description Emergence of resistance to chlorhexidine (among MRSA and select gram-negative bacteria) or mupirocin (among MRSA) for strains isolated from participating units
Time Frame 21 months
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Cost Effectiveness
Hide Description Cost effectiveness of routine care vs decolonization
Time Frame 21 months
Outcome Measure Data Not Reported
10.Post-Hoc Outcome
Title MRSA and VRE Clinical Cultures Among Patients With Devices
Hide Description 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).
Time Frame 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Arm 1: Usual Care Arm 2: Decolonization
Hide Arm/Group Description:
Routine policy for showering or bathing non-critical care patients

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.

Overall Number of Participants Analyzed 15372 23417
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Hazard Ratio
1.17
(1.00 to 1.37)
0.80
(0.69 to 0.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Usual Care, Arm 2: Decolonization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals
11.Post-Hoc Outcome
Title MRSA Clinical Cultures Among Patients With Devices
Hide Description 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).
Time Frame 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Arm 1: Usual Care Arm 2: Decolonization
Hide Arm/Group Description:
Routine policy for showering or bathing non-critical care patients

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.

Overall Number of Participants Analyzed 15372 23417
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Hazard Ratio
1.17
(0.99 to 1.39)
0.87
(0.74 to 1.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Usual Care, Arm 2: Decolonization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0126
Comments Remains significant after adjusting for multiple comparisons
Method Mixed Models Analysis
Comments Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals
12.Post-Hoc Outcome
Title VRE Clinical Cultures Among Patients With Devices
Hide Description 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).
Time Frame 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Arm 1: Usual Care Arm 2: Decolonization
Hide Arm/Group Description:
Routine policy for showering or bathing non-critical care patients

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.

Overall Number of Participants Analyzed 15372 23417
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Hazard Ratio
1.26
(0.85 to 1.86)
0.58
(0.44 to 0.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Usual Care, Arm 2: Decolonization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Remained significant after adjusting for multiple comparisons
Method Mixed Models Analysis
Comments Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals
13.Post-Hoc Outcome
Title All-cause Bloodstream Infections Among Patients With Devices
Hide Description 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.
Time Frame 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Arm 1: Usual Care Arm 2: Decolonization
Hide Arm/Group Description:
Routine policy for showering or bathing non-critical care patients

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.

Overall Number of Participants Analyzed 15372 23417
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Hazard Ratio
1.13
(0.96 to 1.33)
0.81
(0.70 to 0.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Usual Care, Arm 2: Decolonization
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0032
Comments Remained significant after adjusting for multiple comparisons
Method Mixed Models Analysis
Comments Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals
Time Frame Intervention duration (21 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1: Usual Care Arm 2: Decolonization
Hide Arm/Group Description Routine policy for showering or bathing non-critical care patients

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.

All-Cause Mortality
Arm 1: Usual Care Arm 2: Decolonization
Affected / at Risk (%) Affected / at Risk (%)
Total   0/156889 (0.00%)      0/183013 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: Usual Care Arm 2: Decolonization
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/156889 (0.00%)      0/183013 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1: Usual Care Arm 2: Decolonization
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/156889 (0.00%)      25/183013 (0.01%)    
Skin and subcutaneous tissue disorders     
Diffuse rash *  0/156889 (0.00%)  0 5/183013 (0.00%)  5
Diffuse itching *  0/156889 (0.00%)  0 1/183013 (0.00%)  1
Mild rash on trunk *  0/156889 (0.00%)  0 4/183013 (0.00%)  4
Mild rash, location unknown *  0/156889 (0.00%)  0 1/183013 (0.00%)  1
Mild rash on limbs *  0/156889 (0.00%)  0 2/183013 (0.00%)  2
Mild rash on limbs, trunk *  0/156889 (0.00%)  0 6/183013 (0.00%)  6
Mild rash on groin *  0/156889 (0.00%)  0 1/183013 (0.00%)  1
Mild rash on limbs, face *  0/156889 (0.00%)  0 1/183013 (0.00%)  1
Mild rash on limbs, groin *  0/156889 (0.00%)  0 1/183013 (0.00%)  1
Mild rash on limbs, trunk, face *  0/156889 (0.00%)  0 1/183013 (0.00%)  1
Mild rash on limbs, trunk, groin *  0/156889 (0.00%)  0 1/183013 (0.00%)  1
Mild rash on neck, forehead *  0/156889 (0.00%)  0 1/183013 (0.00%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Susan Huang, Principal Investigator & Medical Director of Epidemiology and Infection Prevention
Organization: University of California, Irvine
Phone: 949-824-5073
EMail: sshuang@uci.edu
Layout table for additonal information
Responsible Party: Susan Huang, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02063867     History of Changes
Other Study ID Numbers: 367981
UH2AT007769 ( U.S. NIH Grant/Contract )
UH3AI113337 ( U.S. NIH Grant/Contract )
First Submitted: February 12, 2014
First Posted: February 14, 2014
Results First Submitted: April 29, 2019
Results First Posted: July 12, 2019
Last Update Posted: July 12, 2019