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

This study has been completed.
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 1, 2015
Last verified: September 2015
  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:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Bacteremia [ Time Frame: participants were followed for the duration of ICU stay, median stay 3 days ] [ Designated as safety issue: No ]
    incidence of bacteremia comparing those in treatment and control groups


Secondary Outcome Measures:
  • Central Line Associated-bloodstream Infection (CLABSI) [ Time Frame: participants were followed for the duration of ICU stay, median stay 3 days ] [ Designated as safety issue: No ]
    Comparing incidence of central line-associated bloodstream infections between treatment and control groups


Other Outcome Measures:
  • Bacteremia [ Time Frame: duration of ICU stay, median 3 days ] [ Designated as safety issue: No ]
    per protocol analysis of incidence of bacteremia comparing those in treatment and control groups


Enrollment: 5659
Study Start Date: February 2008
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
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
Results First Received: March 31, 2015
Last Updated: September 1, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
intensive care unit
Healthcare associated infections (HAI)
pediatric

Additional relevant MeSH terms:
Communicable Diseases
Cross Infection
Infection
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Anti-Infective Agents, Local
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on February 11, 2016