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) (REDUCE-MRSA)

• ClinicalTrials.gov Identifier: NCT00980980
• Recruitment Status: Completed
• First Posted: September 21, 2009
• Results First Posted: July 30, 2014
• Last Update Posted: May 2, 2017
• Sponsor: Harvard Pilgrim Health Care
• Collaborators: Agency for Healthcare Research and Quality (AHRQ); Centers for Disease Control and Prevention; Hospital Corporation of America; University of California, Irvine; Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare Institute
• Information provided by (Responsible Party): Richard Platt, Harvard Pilgrim Health Care

• Study Type: Interventional
• Study Design: Allocation: Randomized; Primary Purpose: Prevention
• Condition: Methicillin-resistant Staphylococcus Aureus
• Intervention: Drug: Chlorhexidine bath and nasal mupirocin
• Enrollment: 74256

Participant Flow

Recruitment Details	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.
Pre-assignment Details	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.

Arm/Group Title	Arm 1: Usual Care-Active Surveillance	Arm 2: Targeted Decolonization	Arm 3: Universal Decolonization
Arm/Group Description	Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+	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)	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)
Period Title: Overall Study
Started	16	14	13
Completed	16	13	13
Not Completed	0	1	0
Reason Not Completed
Withdrawal by Hospital	0	1	0

Baseline Characteristics

Arm/Group Title		Arm 1: Usual Care-Active Surveillance	Arm 2: Targeted Decolonization	Arm 3: Universal Decolonization	Total
Arm/Group Description		Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+	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)	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 of all reporting groups
Overall Number of Baseline Participants		39296	39970	43380	122646
Baseline Analysis Population Description		'Number of Participant' totals reflect total Baseline and Intervention participants combined. 45 hospitals were randomized to a study group, 2 dropped due to exclusion criteria, 43 began the assigned intervention. 1 hospital withdrew during the intervention and was included in as-assigned analyses.
Age, Continuous; Median (Inter-Quartile Range); Unit of measure: Years	Number Analyzed	39296 participants	39970 participants	43380 participants	122646 participants
Baseline Age		65; (52 to 77)	66; (53 to 77)	65; (51 to 77)	65; (52 to 77)
Intervention Age		65; (52 to 77)	66; (53 to 77)	65; (52 to 77)	65; (52 to 77)
Sex/Gender, Customized [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	39296 participants	39970 participants	43380 participants	122646 participants
Females - Baseline		7465	7183	8314	22962
Males - Baseline		8351	8035	9042	25428
Females - Intervention		11176	11683	12361	35220
Males - Intervention		12304	13069	13663	39036
		[1] Measure Description: Proportion of female study participants, during baseline and intervention study phases.
Overall Number of Participants, by Phase [1]; Measure Type: Number; Unit of measure: Admissions	Number Analyzed	39296 participants	39970 participants	43380 participants	122646 participants
Baseline Participants		15816	15218	17356	48390
Intervention Participants		23480	24752	26024	74256
		[1] Measure Description: This table reflects number of admissions with an ICU stay during the Baseline and Intervention periods, separately. Please note that the table above, "Overall Number of Baseline Participants" reflects the total number of participants for which baseline characteristics were measured, across Baseline and Intervention phases combined.

Outcome Measures

1. Primary Outcome

Title	Main Outcome: Patients With Nosocomial MRSA Clinical Cultures
Description	Hazard ratio for ICU-attributable MRSA+ clinical cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm.

Arm/Group Title	Arm 1: Usual Care-Active Surveillance	Arm 2: Targeted Decolonization	Arm 3: Universal Decolonization
Arm/Group Description:	Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+	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)	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 Number of Participants Analyzed	39296	39970	43380
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: hazard ratio
	0.92; (0.77 to 1.10)	0.75; (0.63 to 0.89)	0.63; (0.52 to 0.75)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Usual Care-Active Surveillance, Arm 2: Targeted Decolonization, Arm 3: Universal Decolonization
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.01
	Comments	[Not Specified]
	Method	Proportional-hazards models
	Comments	Proportional-hazards models with shared frailties accounted for clustering within hospitals.

2. Secondary Outcome

Title	MRSA Bloodstream Infection
Description	Hazard ratio for ICU-attributable MRSA+ blood cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm.

Arm/Group Title	Arm 1: Usual Care-Active Surveillance	Arm 2: Targeted Decolonization	Arm 3: Universal Decolonization
Arm/Group Description:	Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+	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)	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 Number of Participants Analyzed	39296	39970	43380
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: hazard ratio
	1.23; (0.82 to 1.85)	1.23; (0.80 to 1.90)	0.72; (0.48 to 1.08)

3. Secondary Outcome

Title	ICU-attributable All-pathogen Bloodstream Infection
Description	Hazard ratio for ICU-attributable positive blood culture from any pathogen, comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm.

Arm/Group Title	Arm 1: Usual Care-Active Surveillance	Arm 2: Targeted Decolonization	Arm 3: Universal Decolonization
Arm/Group Description:	Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+	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)	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 Number of Participants Analyzed	39296	39970	43380
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Hazard ratio
	0.99; (0.84 to 1.16)	0.78; (0.66 to 0.91)	0.56; (0.49 to 0.65)

4. Secondary Outcome

Title	Intervention Impact on Healthcare Costs
Description	Costs (in dollars) per 1000 ICU-admissions associated with 3 ICU strategies to reduce ICU Bloodstream infection (BSI), (Arms 1-3).
Time Frame	12-month period

Outcome Measure Data

Analysis Population Description

Annual adult ICU admissions per hospital, over the course of 1 year.

Arm/Group Title	Arm 1: Usual Care-Active Surveillance	Arm 2: Targeted Decolonization	Arm 3: Universal Decolonization
Arm/Group Description:	Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+	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)	Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of 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 Number of Participants Analyzed	1000	1000	1000
Measure Type: Number; Unit of Measure: Dollars per 1000 ICU-admissions
Cost of MRSA screening tests	9,120	9,120	0
Cost of contact precautions	69,010	68,830	24,890
Cost of decolonization	0	4,679	36,500
ICU costs (not including intervention costs)	19,320,000	19,250,000	19,170,000

5. Secondary Outcome

Title	Blood Culture Contamination Rates
Description	Odds ratio for ICU-attributable blood culture contamination rates, comparing Baseline to Intervention period across Arms, accounting for clustering by hospital.
Time Frame	24-month time frame for this analysis represents a 6-month baseline and 18-month intervention period.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm 1: Usual Care-Active Surveillance	Arm 2: Targeted Decolonization	Arm 3: Universal Decolonization
Arm/Group Description:	Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+	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)	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 Number of Participants Analyzed	4154	4141	4982
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Odds Ratio
As randomized, unadjusted	0.74; (0.58 to 0.94)	0.94; (0.72 to 1.23)	0.56; (0.44 to 0.71)
As randomized, adjusted	0.73; (0.57 to 0.94)	0.93; (0.7 to 1.22)	0.55; (0.43 to 0.71)

6. Secondary Outcome

Title	Intervention Impact on Bacteriuria and Candiduria
Description	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.
Time Frame	30-month time frame represents 12-month baseline and 18-month intervention periods.

Outcome Measure Data

Analysis Population Description

The number of participants analyzed reflects the combined total of baseline and intervention admissions with an ICU stay, for each arm.

Arm/Group Title	Arm 1: Usual Care-Active Surveillance	Arm 2: Targeted Decolonization	Arm 3: Universal Decolonization
Arm/Group Description:	Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+	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)	Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of 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 Number of Participants Analyzed	39296	39970	43380
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Hazard Ratio
High-level bacteriuria (all patients)	1.02; (0.88 to 1.18)	0.88; (0.76 to 1.02)	0.87; (0.77 to 1.00)
High-level bacteriuria (women)	0.97; (0.80 to 1.17)	0.83; (0.70 to 1.00)	0.93; (0.79 to 1.09)
High-level bacteriuria (men)	1.09; (0.85 to 1.40)	1.01; (0.79 to 1.29)	.78; (.63 to .98)
High-level candiduria (all patients)	1.14; (.95 to 1.37)	.99; (.83 to 1.18)	.83; (.70 to .99)
High-level candiduria (women)	1.09; (.88 to 1.36)	1.00; (.81 to 1.24)	.94; (.76 to 1.16)
High-level candiduria (men)	1.21; (.88 to 1.68)	1.01; (.73 to 1.39)	.63; (.45 to .89)
Any bacteriuria (all patients)	.95; (.84 to 1.09)	.92; (.8 to 1.04)	.86; (.77 to .97)
Any bacteriuria (women)	.91; (.77 to 1.08)	.86; (.73 to 1.01)	.95; (.82 to 1.10)
Any bacteriuria (men)	1.01; (.81 to 1.25)	1.04; (.83 to 1.3)	.74; (0.61 to .9)

7. Secondary Outcome

Title	Intervention Impact on Mupirocin Susceptibility of MRSA Isolates
Description	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.
Time Frame	25-month time frame represents 7-month baseline and 18-month intervention periods

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm 1: Usual Care-Active Surveillance	Arm 2: Targeted Decolonization	Arm 3: Universal Decolonization
Arm/Group Description:	Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+	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)	Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of 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 Number of Participants Analyzed	29643	28297	32601
Overall Number of Units Analyzed; Type of Units Analyzed: MRSA+ isolates	1303	1460	410
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Odds Ratio
Clinical MRSA: LLMR	1.0; (0.22 to 4.85)	1.4; (0.34 to 6.14)	0.5; (0.1 to 2.14)
Clinical MRSA: HLMR	0.8; (0.11 to 5.68)	0.9; (0.15 to 5.44)	0.7; (0.16 to 3.01)
ICU-attributable MRSA: LLMR	1.7; (0.37 to 7.55)	0.4; (0.01 to 99)	0.7; (0.10 to 4.64)
ICU-attributable MRSA: HLMR	1.5; (0.25 to 9.02)	0.7; (0.09 to 5.06)	1.4; (0.134 to 15.63)

8. Secondary Outcome

Title	Intervention Impact on Chlorhexidine Susceptibility of MRSA Isolates
Description	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.
Time Frame	25-month time frame represents 7-month baseline and 18-month intervention periods

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm 1: Usual Care-Active Surveillance	Arm 2: Targeted Decolonization	Arm 3: Universal Decolonization
Arm/Group Description:	Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+	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)	Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of 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 Number of Participants Analyzed	29643	28297	32601
Overall Number of Units Analyzed; Type of Units Analyzed: MRSA+ isolates	1303	1460	410
Measure Type: Number; Unit of Measure: MRSA isolates non-susceptible to CHG
	2	0	0

Adverse Events

Time Frame	18 months
Adverse Event Reporting Description	Adverse event monitoring and reporting occurred during intervention only, as decolonizing agents were not used during the baseline period.
Arm/Group Title	Arm 1: Usual Care-Active Surveillance		Arm 2: Targeted Decolonization		Arm 3: Universal Decolonization
Arm/Group Description	Active Surveillance in All Adult ICUs Contact Precautions for MRSA+		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)		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)
All-Cause Mortality
	Arm 1: Usual Care-Active Surveillance		Arm 2: Targeted Decolonization		Arm 3: Universal Decolonization
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--
Serious Adverse Events
	Arm 1: Usual Care-Active Surveillance		Arm 2: Targeted Decolonization		Arm 3: Universal Decolonization
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23480 (0.00%)		0/24752 (0.00%)		0/26024 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Arm 1: Usual Care-Active Surveillance		Arm 2: Targeted Decolonization		Arm 3: Universal Decolonization
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23480 (0.00%)		2/24752 (0.01%)		5/26024 (0.02%)
Skin and subcutaneous tissue disorders
Mild † [1]	0/23480 (0.00%)	0	2/24752 (0.01%)	2	5/26024 (0.02%)	5
Moderate † [2]	0/23480 (0.00%)	0	0/24752 (0.00%)	0	0/26024 (0.00%)	0
Severe † [3]	0/23480 (0.00%)	0	0/24752 (0.00%)	0	0/26024 (0.00%)	0
† Indicates events were collected by systematic assessment; [1] A mild adverse event included any criteria less than moderate; [2] A moderate adverse event included any moderate erythema, scaling or blistering that involves >30% body surface area; [3] A severe adverse event included any severe erythema, scaling or blistering that involves >30% body surface area

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Susan Huang
• Organization: University of California, Irvine
• Phone: 949-824-5073
• EMail: sshuang@uci.edu

Publications of Results:

Huang SS, Septimus E, Kleinman K, Moody J, Hickok J, Avery TR, Lankiewicz J, Gombosev A, Terpstra L, Hartford F, Hayden MK, Jernigan JA, Weinstein RA, Fraser VJ, Haffenreffer K, Cui E, Kaganov RE, Lolans K, Perlin JB, Platt R; CDC Prevention Epicenters Program; AHRQ DECIDE Network and Healthcare-Associated Infections Program. Targeted versus universal decolonization to prevent ICU infection. N Engl J Med. 2013 Jun 13;368(24):2255-65. doi: 10.1056/NEJMoa1207290. Epub 2013 May 29. Erratum In: N Engl J Med. 2013 Aug 8;369(6):587. N Engl J Med. 2014 Feb 27;370(9):886.

Other Publications:

Platt R, Takvorian SU, Septimus E, Hickok J, Moody J, Perlin J, Jernigan JA, Kleinman K, Huang SS. Cluster randomized trials in comparative effectiveness research: randomizing hospitals to test methods for prevention of healthcare-associated infections. Med Care. 2010 Jun;48(6 Suppl):S52-7. doi: 10.1097/MLR.0b013e3181dbebcf.

Huang SS, Septimus E, Platt R. Targeted decolonization to prevent ICU infections. N Engl J Med. 2013 Oct 10;369(15):1470-1. doi: 10.1056/NEJMc1309704. No abstract available.

• Responsible Party: Richard Platt, Harvard Pilgrim Health Care
• ClinicalTrials.gov Identifier: NCT00980980
• Other Study ID Numbers: PH000223K; HHSA2902005003I; TO #11
• First Submitted: September 19, 2009
• First Posted: September 21, 2009
• Results First Submitted: May 14, 2014
• Results First Posted: July 30, 2014
• Last Update Posted: May 2, 2017