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

May 19, 2017 updated by: Johns Hopkins University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5659

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20010
        • Children's National Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central Line Associated-bloodstream Infection (CLABSI)
Time Frame: 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
participants were followed for the duration of ICU stay, median stay 3 days

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Sage Products, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

October 24, 2007

First Submitted That Met QC Criteria

October 24, 2007

First Posted (Estimate)

October 25, 2007

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

May 19, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00006799

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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