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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sage Products, Inc.
Information provided by (Responsible Party):
Trish Perl, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00549393
First received: October 24, 2007
Last updated: September 18, 2012
Last verified: September 2012
History of Changes
  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 2
Phase 3

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:

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 2013
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 Perl, Health System Epidemologist, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00549393     History of Changes
Other Study ID Numbers: NA_00006799
Study First Received: October 24, 2007
Last Updated: September 18, 2012
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
Chlorhexidine gluconate
Anti-Infective Agents, Local
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on May 16, 2013