Trial Outcomes & Findings for Mupirocin-Iodophor ICU Decolonization Swap Out Trial (NCT NCT03140423)
NCT ID: NCT03140423
Last Updated: 2025-03-30
Results Overview
Methicillin-resistant Staphylococcus aureus (MRSA) and Methicillin-susceptible Staphylococcus aureus (MSSA) clinical cultures attributable to participating ICUs. Defined as occurring \>2 days into a participating ICU stay through 2 days following ICU discharge. NOTE: this outcome is intended for the primary manuscript.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
353323 participants
Primary outcome timeframe
18-month intervention
Results posted on
2025-03-30
Participant Flow
137 out of 178 HCA Healthcare hospitals were recruited for this trial of adult ICUs. There was an 18-month intervention period from November 1, 2017 through April 30, 2019.
353,323 patients were involved in the intervention period among adult ICUs from the 137 participating hospitals.
Unit of analysis: Hospitals
Participant milestones
| Measure |
Arm 1: Routine Care (Mupirocin/CHG)
ICU nasal decolonization with mupirocin twice daily for 5 days in the context of chlorhexidine for daily bathing
Arm 1. Routine Care (Mupirocin/CHG): The intervention / decolonization regimen will consist of 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.
|
Arm 2: Iodophor/CHG Decolonization
ICU nasal decolonization with iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing
Arm 2. Iodophor/CHG Decolonization: The intervention / decolonization regimen will consist of 5 days of topical intranasal iodophor (10% povidone-iodine nasal swabs) (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.
|
|---|---|---|
|
Overall Study
STARTED
|
168301 68
|
185022 69
|
|
Overall Study
COMPLETED
|
168301 66
|
185022 68
|
|
Overall Study
NOT COMPLETED
|
0 2
|
0 1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Overall number of participants reflect participants during the Intervention period.
Baseline characteristics by cohort
| Measure |
Arm 1: Routine Care (Mupirocin/CHG)
n=168301 Participants
ICU nasal decolonization with mupirocin twice daily for 5 days in the context of chlorhexidine for daily bathing
Arm 1. Routine Care (Mupirocin/CHG): The intervention / decolonization regimen will consist of 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.
|
Arm 2: Iodophor/CHG Decolonization
n=185022 Participants
ICU nasal decolonization with iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing
Arm 2. Iodophor/CHG Decolonization: The intervention / decolonization regimen will consist of 5 days of topical intranasal iodophor (10% povidone-iodine nasal swabs) (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.
|
Total
n=353323 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
66.0 years
n=168301 Participants • Overall number of participants reflect participants during the Intervention period.
|
66.0 years
n=185022 Participants • Overall number of participants reflect participants during the Intervention period.
|
66.0 years
n=353323 Participants • Overall number of participants reflect participants during the Intervention period.
|
|
Sex/Gender, Customized
Sex · Female
|
78074 Participants
n=168219 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
|
85194 Participants
n=184950 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
|
163268 Participants
n=353169 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
|
|
Sex/Gender, Customized
Sex · Male
|
90145 Participants
n=168219 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
|
99756 Participants
n=184950 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
|
189901 Participants
n=353169 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
21901 Participants
n=155666 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
|
27776 Participants
n=171982 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
|
49677 Participants
n=327648 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
|
|
Race/Ethnicity, Customized
Race · White
|
126749 Participants
n=155666 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
|
135060 Participants
n=171982 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
|
261809 Participants
n=327648 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
|
|
Race/Ethnicity, Customized
Race · Other
|
7016 Participants
n=155666 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
|
9146 Participants
n=171982 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
|
16162 Participants
n=327648 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
|
PRIMARY outcome
Timeframe: 18-month interventionPopulation: The total number of participants analyzed reported here is from the intervention period.
Methicillin-resistant Staphylococcus aureus (MRSA) and Methicillin-susceptible Staphylococcus aureus (MSSA) clinical cultures attributable to participating ICUs. Defined as occurring \>2 days into a participating ICU stay through 2 days following ICU discharge. NOTE: this outcome is intended for the primary manuscript.
Outcome measures
| Measure |
Arm 1: Routine Care (Mupirocin/CHG)
n=168301 Participants
ICU nasal decolonization with mupirocin twice daily for 5 days in the context of chlorhexidine for daily bathing
Arm 1. Routine Care (Mupirocin/CHG): The intervention / decolonization regimen will consist of 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.
|
Arm 2: Iodophor/CHG Decolonization
n=185022 Participants
ICU nasal decolonization with iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing
Arm 2. Iodophor/CHG Decolonization: The intervention / decolonization regimen will consist of 5 days of topical intranasal iodophor (10% povidone-iodine nasal swabs) (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.
|
|---|---|---|
|
Number of Participants With ICU-attributable Staphylococcus Aureus Clinical Cultures
|
2708 participants
|
3563 participants
|
SECONDARY outcome
Timeframe: 18-month interventionPopulation: The total number of participants analyzed reported here is from the intervention period.
Methicillin-resistant Staphylococcus aureus (MRSA) clinical cultures attributable to participating ICUs. Defined as occurring \>2 days into a participating ICU stay through 2 days following ICU discharge. NOTE: this outcome is intended for the primary manuscript.
Outcome measures
| Measure |
Arm 1: Routine Care (Mupirocin/CHG)
n=168301 Participants
ICU nasal decolonization with mupirocin twice daily for 5 days in the context of chlorhexidine for daily bathing
Arm 1. Routine Care (Mupirocin/CHG): The intervention / decolonization regimen will consist of 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.
|
Arm 2: Iodophor/CHG Decolonization
n=185022 Participants
ICU nasal decolonization with iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing
Arm 2. Iodophor/CHG Decolonization: The intervention / decolonization regimen will consist of 5 days of topical intranasal iodophor (10% povidone-iodine nasal swabs) (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.
|
|---|---|---|
|
Number of Participants With ICU Attributable MRSA Clinical Cultures
|
1377 participants
|
1682 participants
|
SECONDARY outcome
Timeframe: 18-month interventionPopulation: The total number of participants analyzed reported here is from the intervention period.
All-cause bloodstream infection attributable to participating ICUs. Defined as occurring \>2 days into a participating ICU stay through 2 days following ICU discharge.Includes subsets of gram positive (GP), gram negative (GN) and fungal (candida) bloodstream infections, as well as key pathogens such as S. aureus (MRSA and MSSA). NOTE: this outcome is intended for the primary manuscript.
Outcome measures
| Measure |
Arm 1: Routine Care (Mupirocin/CHG)
n=168301 Participants
ICU nasal decolonization with mupirocin twice daily for 5 days in the context of chlorhexidine for daily bathing
Arm 1. Routine Care (Mupirocin/CHG): The intervention / decolonization regimen will consist of 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.
|
Arm 2: Iodophor/CHG Decolonization
n=185022 Participants
ICU nasal decolonization with iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing
Arm 2. Iodophor/CHG Decolonization: The intervention / decolonization regimen will consist of 5 days of topical intranasal iodophor (10% povidone-iodine nasal swabs) (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.
|
|---|---|---|
|
Number of Participants With ICU-attributable Bloodstream Infections
|
1766 participants
|
1956 participants
|
Adverse Events
Arm 1: Routine Care (Mupirocin/CHG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Iodophor/CHG Decolonization
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1: Routine Care (Mupirocin/CHG)
n=168301 participants at risk
ICU nasal decolonization with mupirocin twice daily for 5 days in the context of chlorhexidine for daily bathing
Arm 1. Routine Care (Mupirocin/CHG): The intervention / decolonization regimen will consist of 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.
|
Arm 2: Iodophor/CHG Decolonization
n=185022 participants at risk
ICU nasal decolonization with iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing
Arm 2. Iodophor/CHG Decolonization: The intervention / decolonization regimen will consist of 5 days of topical intranasal iodophor (10% povidone-iodine nasal swabs) (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Other (Not Including Serious) Adverse Event
|
0.00%
0/168301 • 18 Months
There were 2 adverse events, both in the Iodophor-CHG group. One involved mild nasal pruritus, and one involved total body hives requiring treatment. Both resolved on discontinuation of decolonization.
|
0.00%
2/185022 • Number of events 2 • 18 Months
There were 2 adverse events, both in the Iodophor-CHG group. One involved mild nasal pruritus, and one involved total body hives requiring treatment. Both resolved on discontinuation of decolonization.
|
Additional Information
Dr. Susan S. Huang, MD, MPH
Division of Infectious Diseases, University of California Irvine School of Medicine
Phone: (714) 456-5047
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place