Multicenter Trial of Daily Chlorhexidine Bathing to Reduce Nosocomial Infections (CBET)

August 6, 2007 updated by: Hunter Holmes Mcguire Veteran Affairs Medical Center

Multicenter Evaluation of The Effectiveness of Source Control With Daily Chlorhexidine Skin Preparation in Reducing Nosocomial Infections Including MRSA and VRE

To determine if daily bathing with chlorhexidine impregnated washcloths will reduce the incidence of MRSA and VRE within an Intensive Care Unit (ICU) or ward setting.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a cluster randomized, crossover-controlled trial with wards as the units of randomization. The trial will predominantly take place in ICU's but may include any acute care ward that has active surveillance for MRSA and or VRE in place (i.e., Bone Marrow transplant units, Oncology wards, etc.) Units will be randomly assigned to utilize two bathing routines in a random order. Each bathing routine will be utilized on all admitted patients to the unit for a six month study period for a total study duration of 12 months. The two bathing routines will include either the use of the Comfort® Bath Washcloth System (control) or the use of 2% Chlorhexidine Gluconate Cloth. Randomized units will either start with 2% Chlorhexidine Gluconate Cloth for six months and then switch to Comfort™ Bath Washcloth for the remaining six month period or the reverse order. Data collection will include all surveillance and clinical cultures for MRSA and or VRE and all bloodstream infections.

Study Type

Observational

Enrollment (Anticipated)

14000

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Northwestern Memorial Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maureen K Bolon, MD
        • Sub-Investigator:
          • Gary Noskins, MD
    • Iowa
      • Iowa City, Iowa, United States, 52242-1081
        • Not yet recruiting
        • University of Iowa Hospitals and Clinics
        • Contact:
        • Principal Investigator:
          • Loreen Herwaldt, MD
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Not yet recruiting
        • Johns Hopkins Hospital
        • Contact:
          • Trish M Perl, MD, MSc
          • Phone Number: 410-955-8384
          • Email: tperl@jhmi.edu
        • Contact:
        • Principal Investigator:
          • Trish M Perl, MD, MSc
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Not yet recruiting
        • Brigham and Women's Hospital
        • Contact:
        • Principal Investigator:
          • Debbie Yokoe, MD, MPH
    • Missouri
      • St. Louis, Missouri, United States, 63110
    • New York
      • New York, New York, United States, 10021
        • Not yet recruiting
        • Memorial Sloan-Kettering Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kent A Sepkowitz, MD
        • Sub-Investigator:
          • Gianna Zucotti, MD
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Recruiting
        • Hunter Holmes Mcguire Veteran Affairs Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael W Climo, MD
        • Sub-Investigator:
          • Edward S Wong, MD
        • Sub-Investigator:
          • Jane A Cecil, MD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients admitted to study units during the proposed study interval are eligible for inclusion in the study

Exclusion Criteria:

  • Patients with known allergies to chlorhexidine gluconate or any other ingredients in the product
  • Patients with burns that include a high percentage of disrupted body surface area
  • Use in patients undergoing lumbar punctures or contact with the meninges
  • Patients with large open skin wounds; and
  • Children less than 18 years old

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

Collaborators and Investigators

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

Sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center

Collaborators

Centers for Disease Control and Prevention
Sage Products, Inc.

Investigators

  • Principal Investigator: Loreen Herwaldt, MD, University of Iowa
  • Study Director: Michael W Climo, MD, Hunter Holmes Mcguire Veteran Affairs Medical Center
  • Principal Investigator: Edward S Wong, MD, Hunter Holmes Mcguire Veteran Affairs Medical Center
  • Principal Investigator: Jane A Cecil, MD, Hunter Holmes Mcguire Veteran Affairs Medical Center
  • Principal Investigator: Kent Sepkowitz, MD, Weil Medical College of Cornell University
  • Principal Investigator: Trish M Perl, MD, MSc, Johns Hopkins University
  • Principal Investigator: Debbie Yokoe, MD, MPH, Harvard School of Medicine, Brigham and Women's Hospital
  • Principal Investigator: Maureen Bolon, MD, Northwestern University Feinberg School of Medicine
  • Principal Investigator: Dave K Warren, MD, Washington University School of Medicine

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

August 1, 2007

Study Completion (Anticipated)

September 1, 2009

Study Registration Dates

First Submitted

July 16, 2007

First Submitted That Met QC Criteria

July 16, 2007

First Posted (Estimate)

July 17, 2007

Study Record Updates

Last Update Posted (Estimate)

August 7, 2007

Last Update Submitted That Met QC Criteria

August 6, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI06-003

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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