Trial Outcomes & Findings for Cluster Randomized Trial of Hospitals to Assess Impact of Targeted Versus Universal Strategies to Reduce Methicillin-resistant Staphylococcus Aureus (MRSA) in Intensive Care Units (ICUs) (NCT NCT00980980)
NCT ID: NCT00980980
Last Updated: 2017-05-02
Results Overview
Hazard ratio for ICU-attributable MRSA+ clinical cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
74256 participants
Primary outcome timeframe
The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.
Results posted on
2017-05-02
Participant Flow
45 out of 165 Hospital Corporation of America (HCA) hospitals were recruited for this trial of adult ICUs. There was a 12-month baseline period from January 1 through December 31, 2009; a phase-in period from January 1 through April 7, 2010; and an 18-month intervention period from April 8, 2010 through September 30, 2011.
74,256 patients were involved in the intervention period among adult ICUs from the 43 participating hospitals. Routinely collected information for about 48,390 individuals cared for during the baseline period was used for comparison to the experience of the patients in all three arms of the Intervention period.
Participant milestones
| Measure |
Arm 1: Usual Care-Active Surveillance
Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
|
Arm 2: Targeted Decolonization
Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
Arm 3: Universal Decolonization
Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
13
|
|
Overall Study
COMPLETED
|
16
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm 1: Usual Care-Active Surveillance
Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
|
Arm 2: Targeted Decolonization
Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
Arm 3: Universal Decolonization
Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
|---|---|---|---|
|
Overall Study
Withdrawal by Hospital
|
0
|
1
|
0
|
Baseline Characteristics
Cluster Randomized Trial of Hospitals to Assess Impact of Targeted Versus Universal Strategies to Reduce Methicillin-resistant Staphylococcus Aureus (MRSA) in Intensive Care Units (ICUs)
Baseline characteristics by cohort
| Measure |
Arm 1: Usual Care-Active Surveillance
n=39296 Participants
Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
|
Arm 2: Targeted Decolonization
n=39970 Participants
Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
Arm 3: Universal Decolonization
n=43380 Participants
Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
Total
n=122646 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Baseline Age
|
65 Years
n=5 Participants
|
66 Years
n=7 Participants
|
65 Years
n=5 Participants
|
65 Years
n=4 Participants
|
|
Age, Continuous
Intervention Age
|
65 Years
n=5 Participants
|
66 Years
n=7 Participants
|
65 Years
n=5 Participants
|
65 Years
n=4 Participants
|
|
Sex/Gender, Customized
Females - Baseline
|
7465 participants
n=5 Participants
|
7183 participants
n=7 Participants
|
8314 participants
n=5 Participants
|
22962 participants
n=4 Participants
|
|
Sex/Gender, Customized
Males - Baseline
|
8351 participants
n=5 Participants
|
8035 participants
n=7 Participants
|
9042 participants
n=5 Participants
|
25428 participants
n=4 Participants
|
|
Sex/Gender, Customized
Females - Intervention
|
11176 participants
n=5 Participants
|
11683 participants
n=7 Participants
|
12361 participants
n=5 Participants
|
35220 participants
n=4 Participants
|
|
Sex/Gender, Customized
Males - Intervention
|
12304 participants
n=5 Participants
|
13069 participants
n=7 Participants
|
13663 participants
n=5 Participants
|
39036 participants
n=4 Participants
|
|
Overall Number of Participants, by Phase
Baseline Participants
|
15816 Admissions
n=5 Participants
|
15218 Admissions
n=7 Participants
|
17356 Admissions
n=5 Participants
|
48390 Admissions
n=4 Participants
|
|
Overall Number of Participants, by Phase
Intervention Participants
|
23480 Admissions
n=5 Participants
|
24752 Admissions
n=7 Participants
|
26024 Admissions
n=5 Participants
|
74256 Admissions
n=4 Participants
|
PRIMARY outcome
Timeframe: The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.Population: The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm.
Hazard ratio for ICU-attributable MRSA+ clinical cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.
Outcome measures
| Measure |
Arm 1: Usual Care-Active Surveillance
n=39296 Participants
Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
|
Arm 2: Targeted Decolonization
n=39970 Participants
Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
Arm 3: Universal Decolonization
n=43380 Participants
Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
|---|---|---|---|
|
Main Outcome: Patients With Nosocomial MRSA Clinical Cultures
|
0.92 hazard ratio
Interval 0.77 to 1.1
|
0.75 hazard ratio
Interval 0.63 to 0.89
|
0.63 hazard ratio
Interval 0.52 to 0.75
|
SECONDARY outcome
Timeframe: The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.Population: The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm.
Hazard ratio for ICU-attributable MRSA+ blood cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.
Outcome measures
| Measure |
Arm 1: Usual Care-Active Surveillance
n=39296 Participants
Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
|
Arm 2: Targeted Decolonization
n=39970 Participants
Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
Arm 3: Universal Decolonization
n=43380 Participants
Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
|---|---|---|---|
|
MRSA Bloodstream Infection
|
1.23 hazard ratio
Interval 0.82 to 1.85
|
1.23 hazard ratio
Interval 0.8 to 1.9
|
0.72 hazard ratio
Interval 0.48 to 1.08
|
SECONDARY outcome
Timeframe: The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.Population: The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm.
Hazard ratio for ICU-attributable positive blood culture from any pathogen, comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.
Outcome measures
| Measure |
Arm 1: Usual Care-Active Surveillance
n=39296 Participants
Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
|
Arm 2: Targeted Decolonization
n=39970 Participants
Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
Arm 3: Universal Decolonization
n=43380 Participants
Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
|---|---|---|---|
|
ICU-attributable All-pathogen Bloodstream Infection
|
0.99 Hazard ratio
Interval 0.84 to 1.16
|
0.78 Hazard ratio
Interval 0.66 to 0.91
|
0.56 Hazard ratio
Interval 0.49 to 0.65
|
SECONDARY outcome
Timeframe: 12-month periodPopulation: Annual adult ICU admissions per hospital, over the course of 1 year.
Costs (in dollars) per 1000 ICU-admissions associated with 3 ICU strategies to reduce ICU Bloodstream infection (BSI), (Arms 1-3).
Outcome measures
| Measure |
Arm 1: Usual Care-Active Surveillance
n=1000 Participants
Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
|
Arm 2: Targeted Decolonization
n=1000 Participants
Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
Arm 3: Universal Decolonization
n=1000 Participants
Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
|---|---|---|---|
|
Intervention Impact on Healthcare Costs
Cost of MRSA screening tests
|
9,120 Dollars per 1000 ICU-admissions
|
9,120 Dollars per 1000 ICU-admissions
|
0 Dollars per 1000 ICU-admissions
|
|
Intervention Impact on Healthcare Costs
Cost of contact precautions
|
69,010 Dollars per 1000 ICU-admissions
|
68,830 Dollars per 1000 ICU-admissions
|
24,890 Dollars per 1000 ICU-admissions
|
|
Intervention Impact on Healthcare Costs
Cost of decolonization
|
0 Dollars per 1000 ICU-admissions
|
4,679 Dollars per 1000 ICU-admissions
|
36,500 Dollars per 1000 ICU-admissions
|
|
Intervention Impact on Healthcare Costs
ICU costs (not including intervention costs)
|
19,320,000 Dollars per 1000 ICU-admissions
|
19,250,000 Dollars per 1000 ICU-admissions
|
19,170,000 Dollars per 1000 ICU-admissions
|
SECONDARY outcome
Timeframe: 24-month time frame for this analysis represents a 6-month baseline and 18-month intervention period.Population: The number of participants analyzed reflects the combined total of baseline and intervention admissions, with an ICU stay and a blood draw set, for each arm.
Odds ratio for ICU-attributable blood culture contamination rates, comparing Baseline to Intervention period across Arms, accounting for clustering by hospital.
Outcome measures
| Measure |
Arm 1: Usual Care-Active Surveillance
n=4154 Participants
Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
|
Arm 2: Targeted Decolonization
n=4141 Participants
Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
Arm 3: Universal Decolonization
n=4982 Participants
Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
|---|---|---|---|
|
Blood Culture Contamination Rates
As randomized, unadjusted
|
0.74 Odds Ratio
Interval 0.58 to 0.94
|
0.94 Odds Ratio
Interval 0.72 to 1.23
|
0.56 Odds Ratio
Interval 0.44 to 0.71
|
|
Blood Culture Contamination Rates
As randomized, adjusted
|
0.73 Odds Ratio
Interval 0.57 to 0.94
|
0.93 Odds Ratio
Interval 0.7 to 1.22
|
0.55 Odds Ratio
Interval 0.43 to 0.71
|
SECONDARY outcome
Timeframe: 30-month time frame represents 12-month baseline and 18-month intervention periods.Population: The number of participants analyzed reflects the combined total of baseline and intervention admissions with an ICU stay, for each arm.
Proportional hazard ratio for as-randomized, unadjusted, ICU-attributable bacteriuria, comparing Baseline to Intervention period across Arms, accounting for clustering by hospital. High-level bacteriuria is defined as ≥50,000 CFU/mL, high-level candiduria is defined as ≥50,000 CFU/mL.
Outcome measures
| Measure |
Arm 1: Usual Care-Active Surveillance
n=39296 Participants
Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
|
Arm 2: Targeted Decolonization
n=39970 Participants
Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
Arm 3: Universal Decolonization
n=43380 Participants
Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
|---|---|---|---|
|
Intervention Impact on Bacteriuria and Candiduria
High-level bacteriuria (all patients)
|
1.02 Hazard Ratio
Interval 0.88 to 1.18
|
0.88 Hazard Ratio
Interval 0.76 to 1.02
|
0.87 Hazard Ratio
Interval 0.77 to 1.0
|
|
Intervention Impact on Bacteriuria and Candiduria
High-level bacteriuria (women)
|
0.97 Hazard Ratio
Interval 0.8 to 1.17
|
0.83 Hazard Ratio
Interval 0.7 to 1.0
|
0.93 Hazard Ratio
Interval 0.79 to 1.09
|
|
Intervention Impact on Bacteriuria and Candiduria
High-level bacteriuria (men)
|
1.09 Hazard Ratio
Interval 0.85 to 1.4
|
1.01 Hazard Ratio
Interval 0.79 to 1.29
|
.78 Hazard Ratio
Interval 0.63 to 0.98
|
|
Intervention Impact on Bacteriuria and Candiduria
High-level candiduria (all patients)
|
1.14 Hazard Ratio
Interval 0.95 to 1.37
|
.99 Hazard Ratio
Interval 0.83 to 1.18
|
.83 Hazard Ratio
Interval 0.7 to 0.99
|
|
Intervention Impact on Bacteriuria and Candiduria
High-level candiduria (women)
|
1.09 Hazard Ratio
Interval 0.88 to 1.36
|
1.00 Hazard Ratio
Interval 0.81 to 1.24
|
.94 Hazard Ratio
Interval 0.76 to 1.16
|
|
Intervention Impact on Bacteriuria and Candiduria
High-level candiduria (men)
|
1.21 Hazard Ratio
Interval 0.88 to 1.68
|
1.01 Hazard Ratio
Interval 0.73 to 1.39
|
.63 Hazard Ratio
Interval 0.45 to 0.89
|
|
Intervention Impact on Bacteriuria and Candiduria
Any bacteriuria (all patients)
|
.95 Hazard Ratio
Interval 0.84 to 1.09
|
.92 Hazard Ratio
Interval 0.8 to 1.04
|
.86 Hazard Ratio
Interval 0.77 to 0.97
|
|
Intervention Impact on Bacteriuria and Candiduria
Any bacteriuria (women)
|
.91 Hazard Ratio
Interval 0.77 to 1.08
|
.86 Hazard Ratio
Interval 0.73 to 1.01
|
.95 Hazard Ratio
Interval 0.82 to 1.1
|
|
Intervention Impact on Bacteriuria and Candiduria
Any bacteriuria (men)
|
1.01 Hazard Ratio
Interval 0.81 to 1.25
|
1.04 Hazard Ratio
Interval 0.83 to 1.3
|
.74 Hazard Ratio
Interval 0.61 to 0.9
|
SECONDARY outcome
Timeframe: 25-month time frame represents 7-month baseline and 18-month intervention periodsPopulation: The total number of participants analyzed reflects the combined total of baseline and intervention participants during the outcome time frame, for each arm. The total number of units analyzed reflects the combined total of MRSA+ isolates collected from ICU patients during baseline and intervention phase, for each arm.
Odds ratio for MRSA+ isolates from ICU patients expressing low-level mupirocin resistance (LLMR) and high-level mupirocin resistance (HLMR), comparing baseline to intervention period across arms, accounting for clustering by hospital.
Outcome measures
| Measure |
Arm 1: Usual Care-Active Surveillance
n=1303 MRSA+ isolates
Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
|
Arm 2: Targeted Decolonization
n=1460 MRSA+ isolates
Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
Arm 3: Universal Decolonization
n=410 MRSA+ isolates
Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
|---|---|---|---|
|
Intervention Impact on Mupirocin Susceptibility of MRSA Isolates
Clinical MRSA: LLMR
|
1.0 Odds Ratio
Interval 0.22 to 4.85
|
1.4 Odds Ratio
Interval 0.34 to 6.14
|
0.5 Odds Ratio
Interval 0.1 to 2.14
|
|
Intervention Impact on Mupirocin Susceptibility of MRSA Isolates
Clinical MRSA: HLMR
|
0.8 Odds Ratio
Interval 0.11 to 5.68
|
0.9 Odds Ratio
Interval 0.15 to 5.44
|
0.7 Odds Ratio
Interval 0.16 to 3.01
|
|
Intervention Impact on Mupirocin Susceptibility of MRSA Isolates
ICU-attributable MRSA: LLMR
|
1.7 Odds Ratio
Interval 0.37 to 7.55
|
0.4 Odds Ratio
Interval 0.01 to 99.0
|
0.7 Odds Ratio
Interval 0.1 to 4.64
|
|
Intervention Impact on Mupirocin Susceptibility of MRSA Isolates
ICU-attributable MRSA: HLMR
|
1.5 Odds Ratio
Interval 0.25 to 9.02
|
0.7 Odds Ratio
Interval 0.09 to 5.06
|
1.4 Odds Ratio
Interval 0.134 to 15.63
|
SECONDARY outcome
Timeframe: 25-month time frame represents 7-month baseline and 18-month intervention periodsPopulation: The total number of participants analyzed reflects the combined total of baseline and intervention participants during the outcome time frame, for each arm. The total number of units analyzed reflects the combined total of MRSA+ isolates collected from ICU patients during baseline and intervention phase, for each arm.
Frequency of MRSA+ isolates from ICU patients with reduced susceptibility to chlorhexidine (CHG) (MIC \>4 μg/ml), comparing baseline to intervention period across arms, accounting for clustering by hospital.
Outcome measures
| Measure |
Arm 1: Usual Care-Active Surveillance
n=1303 MRSA+ isolates
Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
|
Arm 2: Targeted Decolonization
n=1460 MRSA+ isolates
Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
Arm 3: Universal Decolonization
n=410 MRSA+ isolates
Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
|---|---|---|---|
|
Intervention Impact on Chlorhexidine Susceptibility of MRSA Isolates
|
2 MRSA isolates non-susceptible to CHG
|
0 MRSA isolates non-susceptible to CHG
|
0 MRSA isolates non-susceptible to CHG
|
Adverse Events
Arm 1: Usual Care-Active Surveillance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Targeted Decolonization
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm 3: Universal Decolonization
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1: Usual Care-Active Surveillance
n=23480 participants at risk
Active Surveillance in All Adult ICUs Contact Precautions for MRSA+
|
Arm 2: Targeted Decolonization
n=24752 participants at risk
Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
Arm 3: Universal Decolonization
n=26024 participants at risk
Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+
Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Mild
|
0.00%
0/23480 • 18 months
Adverse event monitoring and reporting occurred during intervention only, as decolonizing agents were not used during the baseline period.
|
0.01%
2/24752 • Number of events 2 • 18 months
Adverse event monitoring and reporting occurred during intervention only, as decolonizing agents were not used during the baseline period.
|
0.02%
5/26024 • Number of events 5 • 18 months
Adverse event monitoring and reporting occurred during intervention only, as decolonizing agents were not used during the baseline period.
|
|
Skin and subcutaneous tissue disorders
Moderate
|
0.00%
0/23480 • 18 months
Adverse event monitoring and reporting occurred during intervention only, as decolonizing agents were not used during the baseline period.
|
0.00%
0/24752 • 18 months
Adverse event monitoring and reporting occurred during intervention only, as decolonizing agents were not used during the baseline period.
|
0.00%
0/26024 • 18 months
Adverse event monitoring and reporting occurred during intervention only, as decolonizing agents were not used during the baseline period.
|
|
Skin and subcutaneous tissue disorders
Severe
|
0.00%
0/23480 • 18 months
Adverse event monitoring and reporting occurred during intervention only, as decolonizing agents were not used during the baseline period.
|
0.00%
0/24752 • 18 months
Adverse event monitoring and reporting occurred during intervention only, as decolonizing agents were not used during the baseline period.
|
0.00%
0/26024 • 18 months
Adverse event monitoring and reporting occurred during intervention only, as decolonizing agents were not used during the baseline period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place