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

This study is ongoing, but not recruiting participants.

First Received on October 24, 2007. Last Updated on June 13, 2011 History of Changes

Sponsor:	Johns Hopkins University
Collaborator:	Sage Products, Inc.
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00549393

Purpose

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	Intervention	Phase
Nosocomial Infections	Drug: 2% Chlorhexidine gluconate cloth	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Impact of Daily Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit

Resource links provided by NLM:

Drug Information available for: Chlorhexidine Chlorhexidine digluconate Hibiclens Gluconic acid D-Gluconic acid, monosodium salt Manganese gluconate

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Bacteremia [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Acquisition of MDRO [ Time Frame: 1 year ] [ Designated as safety issue: No ]
CLA-BSI [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	10000
Study Start Date:	February 2008
Estimated Study Completion Date:	June 2012
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	2 Months to 25 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549393

Locations

United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Missouri
Saint Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
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

More Information

No publications provided

Responsible Party:	Trish M. Perl, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00549393 History of Changes
Other Study ID Numbers:	NA_00006799
Study First Received:	October 24, 2007
Last Updated:	June 13, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:

intensive care unit
HAI
pediatric

Additional relevant MeSH terms:

Cross Infection
Infection
Chlorhexidine gluconate
Chlorhexidine
Anti-Infective Agents, Local

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents
Disinfectants

ClinicalTrials.gov processed this record on February 09, 2012