Study of Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00549393
• Collaborator: Sage Products, Inc. (Industry)
• Enrollment: 5,659
• Locations: 5
• Arms: 2
• Duration (Months): 52
• Patients Per Site: 1131.8
• Patients Per Site Per Month: 21.8

Study Details

Study Description

Brief Summary

The investigators propose to conduct a large clinical study to determine if daily bathing with chlorhexidine impregnated cloths will reduce the incidence of healthcare-associated infections in the Pediatric Intensive Care Unit (PICU).

Condition or Disease	Intervention/Treatment	Phase
Nosocomial Infections	Drug: 2% Chlorhexidine gluconate cloth	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 5659 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Impact of Daily Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Daily bathing with 2% chlorhexidine gluconate	Drug: 2% Chlorhexidine gluconate cloth; Daily bathing
No Intervention: 2 Standard bathing with soap and water basin or disposable cloth

Outcome Measures

Primary Outcome Measures

1. Bacteremia [participants were followed for the duration of ICU stay, median stay 3 days]

   incidence of bacteremia comparing those in treatment and control groups

Secondary Outcome Measures

1. Central Line Associated-bloodstream Infection (CLABSI) [participants were followed for the duration of ICU stay, median stay 3 days]

   Comparing incidence of central line-associated bloodstream infections between treatment and control groups

Other Outcome Measures

1. Bacteremia [duration of ICU stay, median 3 days]

   per protocol analysis of incidence of bacteremia comparing those in treatment and control groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Months to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients in pediatric intensive care unit

Exclusion Criteria:

• Patients with a history of an allergic reaction to chlorhexidine

• Patients less than 2 months of age

• Patients with severe skin disease or burn

• Patients with an indwelling epidural catheter or lumbar drain

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's National Medical Center	Washington, D.C.	District of Columbia	United States	20010
2	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
3	Saint Louis Children's Hospital	Saint Louis	Missouri	United States	63110
4	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
5	Seattle Children's Hospital	Seattle	Washington	United States	98105

Sponsors and Collaborators

• Johns Hopkins University
• Sage Products, Inc.

Investigators

• Principal Investigator: Trish M Perl, MD MSc, Johns Hopkins University
• Study Chair: Aaron Milstone, MD MHS, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00549393
• Other Study ID Numbers: NA_00006799
• First Posted: Oct 25, 2007
• Last Update Posted: Jun 14, 2017
• Last Verified: May 1, 2017

• Keywords provided by Johns Hopkins University: intensive care unit; Healthcare associated infections (HAI); pediatric
• Additional relevant MeSH terms: Infections; Communicable Diseases; Cross Infection; Chlorhexidine; Chlorhexidine gluconate

Study Results

Participant Flow

Recruitment Details	The hospital ICU units underwent a crossover study design, so the ICUs recruited participants in the assigned treatment or control group, then the unit had a washout period, then the unit switched to the alternative assignment of intervention or control for a separate population of participants that were admitted into the ICU.
Pre-assignment Detail	5659 enrolled visits in the study, but 712 were excluded from analysis as they did not meet the eligibility criteria

Arm/Group Title	2% Chlorhexidine Gluconate Cloth	Standard Bath
Arm/Group Description	Daily bathing with 2% chlorhexidine gluconate 2% Chlorhexidine gluconate cloth: Daily bathing	Standard bathing with soap and water basin or disposable cloth
Period Title: Period 1 (6 Months)
STARTED	1319	1199
Per Protocol	880	1199
COMPLETED	1319	1199
NOT COMPLETED	0	0
Period Title: Period 1 (6 Months)
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0
Period Title: Period 1 (6 Months)
STARTED	1103	1326
Per Protocol	667	1326
COMPLETED	1103	1326
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Treatment Arm	Control Arm	Total
Arm/Group Description	Daily bathing with 2% chlorhexidine gluconate 2% Chlorhexidine gluconate cloth: Daily bathing	Standard bathing with soap and water basin or disposable cloth	Total of all reporting groups
Overall Participants	2422	2525	4947
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	4.8	4.8	4.8
Sex/Gender, Customized (participants) [Number]
Male	1389 57.3%	1388 55%	2777 56.1%
Female	1033 42.7%	1137 45%	2170 43.9%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	1271 52.5%	1269 50.3%	2540 51.3%
non-Caucasian	1151 47.5%	1256 49.7%	2407 48.7%
PRISM III Score (score) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [score]	5	5	5

Outcome Measures

1. Primary Outcome

Title	Bacteremia
Description	incidence of bacteremia comparing those in treatment and control groups
Time Frame	participants were followed for the duration of ICU stay, median stay 3 days

Outcome Measure Data

Analysis Population Description

Intent to treat population

Arm/Group Title	Treatment Arm	Control Arm
Arm/Group Description	Daily bathing with 2% chlorhexidine gluconate 2% Chlorhexidine gluconate cloth: Daily bathing	Standard bathing with soap and water basin or disposable cloth
Measure Participants	2422	2525
Number (95% Confidence Interval) [events per 1000 at-risk days]	3.52	4.93

2. Secondary Outcome

Title	Central Line Associated-bloodstream Infection (CLABSI)
Description	Comparing incidence of central line-associated bloodstream infections between treatment and control groups
Time Frame	participants were followed for the duration of ICU stay, median stay 3 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm	Control Arm
Arm/Group Description	Daily bathing with 2% chlorhexidine gluconate 2% Chlorhexidine gluconate cloth: Daily bathing	Standard bathing with soap and water basin or disposable cloth
Measure Participants	2422	2525
Number (95% Confidence Interval) [events per 1000 at-risk days]	1.63	3.00

3. Other Pre-specified Outcome

Title	Bacteremia
Description	per protocol analysis of incidence of bacteremia comparing those in treatment and control groups
Time Frame	duration of ICU stay, median 3 days

Outcome Measure Data

Analysis Population Description

Includes per protocol population of 1547 of 2422 in the treatment arm

Arm/Group Title	Treatment	Control
Arm/Group Description	Daily bathing with 2% chlorhexidine gluconate	Standard bathing with soap and water basin or disposable cloth
Measure Participants	1547	2525
Number (95% Confidence Interval) [events per 1000 at-risk days]	3.28	4.93

Adverse Events

Time Frame	participants were followed for the duration of ICU stay, median stay 3 days
Arm/Group Title	Treatment Arm		Control Arm
Arm/Group Description	Daily bathing with 2% chlorhexidine gluconate 2% Chlorhexidine gluconate cloth: Daily bathing		Standard bathing with soap and water basin or disposable cloth
All Cause Mortality
	Treatment Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Treatment Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2422 (0%)		0/2525 (0%)
Other (Not Including Serious) Adverse Events
	Treatment Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	43/2422 (1.8%)		26/2525 (1%)
Skin and subcutaneous tissue disorders
Skin reaction	43/2422 (1.8%)	43	26/2525 (1%)	26

Limitations/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.