Trial Outcomes & Findings for Active Bathing to Eliminate Infection (ABATE Infection) Trial (NCT NCT02063867)
NCT ID: NCT02063867
Last Updated: 2019-07-12
Results Overview
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
COMPLETED
NA
53 participants
21 months
2019-07-12
Participant Flow
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.
Unit of analysis: hospitals
Participant milestones
| Measure |
Arm 1: Usual Care
Routine policy for showering or bathing non-critical care patients
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
156889 26
|
183013 27
|
|
Overall Study
COMPLETED
|
152598 24
|
180048 24
|
|
Overall Study
NOT COMPLETED
|
4291 2
|
2965 3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data not available for 32 patients during the intervention period.
Baseline characteristics by cohort
| Measure |
Arm 1: Usual Care
n=156889 Participants
Routine policy for showering or bathing non-critical care patients
|
Arm 2: Decolonization
n=183013 Participants
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
n=339902 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 18.2 • n=156889 Participants
|
62.6 years
STANDARD_DEVIATION 18.6 • n=183013 Participants
|
62.4 years
STANDARD_DEVIATION 18.4 • n=339902 Participants
|
|
Sex: Female, Male
Female
|
84585 Participants
n=156873 Participants • Data not available for 32 patients during the intervention period.
|
100249 Participants
n=182997 Participants • Data not available for 32 patients during the intervention period.
|
184834 Participants
n=339870 Participants • Data not available for 32 patients during the intervention period.
|
|
Sex: Female, Male
Male
|
72288 Participants
n=156873 Participants • Data not available for 32 patients during the intervention period.
|
82748 Participants
n=182997 Participants • Data not available for 32 patients during the intervention period.
|
155036 Participants
n=339870 Participants • Data not available for 32 patients during the intervention period.
|
|
Race/Ethnicity, Customized
White
|
107261 Participants
n=156889 Participants
|
112067 Participants
n=183013 Participants
|
219328 Participants
n=339902 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
22581 Participants
n=156889 Participants
|
38704 Participants
n=183013 Participants
|
61285 Participants
n=339902 Participants
|
|
Race/Ethnicity, Customized
Black
|
21501 Participants
n=156889 Participants
|
22462 Participants
n=183013 Participants
|
43963 Participants
n=339902 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2021 Participants
n=156889 Participants
|
4175 Participants
n=183013 Participants
|
6196 Participants
n=339902 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
3525 Participants
n=156889 Participants
|
5605 Participants
n=183013 Participants
|
9130 Participants
n=339902 Participants
|
|
Region of Enrollment
United States
|
156889 participants
n=156889 Participants
|
183013 participants
n=183013 Participants
|
339902 participants
n=339902 Participants
|
PRIMARY outcome
Timeframe: 21 monthsPopulation: Unadjusted intention-to-treat analysis. Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)
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
Outcome measures
| Measure |
Arm 1: Usual Care
n=156889 Participants
Routine policy for showering or bathing non-critical care patients
|
Arm 2: Decolonization
n=183013 Participants
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.
|
|---|---|---|
|
MRSA and VRE Clinical Cultures
|
0.87 Hazard Ratio (Intervention vs Baseline)
Interval 0.79 to 0.95
|
0.79 Hazard Ratio (Intervention vs Baseline)
Interval 0.73 to 0.87
|
SECONDARY outcome
Timeframe: 21 monthsPopulation: Unadjusted intention-to-treat analysis. Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)
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
Outcome measures
| Measure |
Arm 1: Usual Care
n=156889 Participants
Routine policy for showering or bathing non-critical care patients
|
Arm 2: Decolonization
n=183013 Participants
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.
|
|---|---|---|
|
Gram-negative Multi-drug Resistant Organism Clinical Cultures
|
0.81 Hazard Ratio (Intervention vs Baseline)
Interval 0.72 to 0.91
|
0.91 Hazard Ratio (Intervention vs Baseline)
Interval 0.82 to 1.0
|
SECONDARY outcome
Timeframe: 21 monthsPopulation: Unadjusted intention-to-treat analysis. Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)
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.
Outcome measures
| Measure |
Arm 1: Usual Care
n=156889 Participants
Routine policy for showering or bathing non-critical care patients
|
Arm 2: Decolonization
n=183013 Participants
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 Bloodstream Infections
|
0.96 Hazard Ratio
Interval 0.85 to 1.08
|
0.90 Hazard Ratio
Interval 0.8 to 1.01
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 21 monthsUrinary tract infections attributable to participating units. Defined as occurring \>2 days into a participating unit stay through 2 days following unit discharge
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 21 monthsBlood culture contamination
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 21 monthsClostridium difficile Infection attributable to participating units
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 21 months30-Day Infectious Readmissions among patients in participating units
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 21 monthsEmergence of resistance to chlorhexidine (among MRSA and select gram-negative bacteria) or mupirocin (among MRSA) for strains isolated from participating units
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 21 monthsCost effectiveness of routine care vs decolonization
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: 21 monthsPopulation: 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)
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).
Outcome measures
| Measure |
Arm 1: Usual Care
n=15372 Participants
Routine policy for showering or bathing non-critical care patients
|
Arm 2: Decolonization
n=23417 Participants
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.
|
|---|---|---|
|
MRSA and VRE Clinical Cultures Among Patients With Devices
|
1.17 Hazard Ratio
Interval 1.0 to 1.37
|
0.80 Hazard Ratio
Interval 0.69 to 0.92
|
POST_HOC outcome
Timeframe: 21 monthsPopulation: 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)
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).
Outcome measures
| Measure |
Arm 1: Usual Care
n=15372 Participants
Routine policy for showering or bathing non-critical care patients
|
Arm 2: Decolonization
n=23417 Participants
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.
|
|---|---|---|
|
MRSA Clinical Cultures Among Patients With Devices
|
1.17 Hazard Ratio
Interval 0.99 to 1.39
|
0.87 Hazard Ratio
Interval 0.74 to 1.02
|
POST_HOC outcome
Timeframe: 21 monthsPopulation: 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)
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).
Outcome measures
| Measure |
Arm 1: Usual Care
n=15372 Participants
Routine policy for showering or bathing non-critical care patients
|
Arm 2: Decolonization
n=23417 Participants
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.
|
|---|---|---|
|
VRE Clinical Cultures Among Patients With Devices
|
1.26 Hazard Ratio
Interval 0.85 to 1.86
|
0.58 Hazard Ratio
Interval 0.44 to 0.78
|
POST_HOC outcome
Timeframe: 21 monthsPopulation: 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)
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.
Outcome measures
| Measure |
Arm 1: Usual Care
n=15372 Participants
Routine policy for showering or bathing non-critical care patients
|
Arm 2: Decolonization
n=23417 Participants
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 Bloodstream Infections Among Patients With Devices
|
1.13 Hazard Ratio
Interval 0.96 to 1.33
|
0.81 Hazard Ratio
Interval 0.7 to 0.94
|
Adverse Events
Arm 1: Usual Care
Arm 2: Decolonization
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1: Usual Care
n=156889 participants at risk
Routine policy for showering or bathing non-critical care patients
|
Arm 2: Decolonization
n=183013 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Diffuse rash
|
0.00%
0/156889 • Intervention duration (21 months)
|
0.00%
5/183013 • Number of events 5 • Intervention duration (21 months)
|
|
Skin and subcutaneous tissue disorders
Diffuse itching
|
0.00%
0/156889 • Intervention duration (21 months)
|
0.00%
1/183013 • Number of events 1 • Intervention duration (21 months)
|
|
Skin and subcutaneous tissue disorders
Mild rash on trunk
|
0.00%
0/156889 • Intervention duration (21 months)
|
0.00%
4/183013 • Number of events 4 • Intervention duration (21 months)
|
|
Skin and subcutaneous tissue disorders
Mild rash, location unknown
|
0.00%
0/156889 • Intervention duration (21 months)
|
0.00%
1/183013 • Number of events 1 • Intervention duration (21 months)
|
|
Skin and subcutaneous tissue disorders
Mild rash on limbs
|
0.00%
0/156889 • Intervention duration (21 months)
|
0.00%
2/183013 • Number of events 2 • Intervention duration (21 months)
|
|
Skin and subcutaneous tissue disorders
Mild rash on limbs, trunk
|
0.00%
0/156889 • Intervention duration (21 months)
|
0.00%
6/183013 • Number of events 6 • Intervention duration (21 months)
|
|
Skin and subcutaneous tissue disorders
Mild rash on groin
|
0.00%
0/156889 • Intervention duration (21 months)
|
0.00%
1/183013 • Number of events 1 • Intervention duration (21 months)
|
|
Skin and subcutaneous tissue disorders
Mild rash on limbs, face
|
0.00%
0/156889 • Intervention duration (21 months)
|
0.00%
1/183013 • Number of events 1 • Intervention duration (21 months)
|
|
Skin and subcutaneous tissue disorders
Mild rash on limbs, groin
|
0.00%
0/156889 • Intervention duration (21 months)
|
0.00%
1/183013 • Number of events 1 • Intervention duration (21 months)
|
|
Skin and subcutaneous tissue disorders
Mild rash on limbs, trunk, face
|
0.00%
0/156889 • Intervention duration (21 months)
|
0.00%
1/183013 • Number of events 1 • Intervention duration (21 months)
|
|
Skin and subcutaneous tissue disorders
Mild rash on limbs, trunk, groin
|
0.00%
0/156889 • Intervention duration (21 months)
|
0.00%
1/183013 • Number of events 1 • Intervention duration (21 months)
|
|
Skin and subcutaneous tissue disorders
Mild rash on neck, forehead
|
0.00%
0/156889 • Intervention duration (21 months)
|
0.00%
1/183013 • Number of events 1 • Intervention duration (21 months)
|
Additional Information
Susan Huang, Principal Investigator & Medical Director of Epidemiology and Infection Prevention
University of California, Irvine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place