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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Hunter Holmes Mcguire Veteran Affairs Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Sage Products, Inc.
Information provided by:
Hunter Holmes Mcguire Veteran Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00502476
First received: July 16, 2007
Last updated: August 6, 2007
Last verified: August 2007
  Purpose

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.


Condition Intervention
Nosocomial Bacteremia
MRSA Colonization
MRSA Infection
VRE Colonization
VRE Infection
Procedure: Bathing with Chlorhexidine Impregnated Washcloths

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Multicenter Evaluation of The Effectiveness of Source Control With Daily Chlorhexidine Skin Preparation in Reducing Nosocomial Infections Including MRSA and VRE

Resource links provided by NLM:


Further study details as provided by Hunter Holmes Mcguire Veteran Affairs Medical Center:

Estimated Enrollment: 14000
Study Start Date: August 2007
Estimated Study Completion Date: September 2009
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502476

Contacts
Contact: Michael W Climo, MD (804) 675-5018 michael.climo@va.gov
Contact: Edward S Wong, MD (804) 675-6792 edward.wong@va.gov

Locations
United States, Illinois
Northwestern Memorial Hospital Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Maureen K Bolon, MD    312-695-5059    m-bolon@NORTHWESTERN.EDU   
Contact: Farida Siddiqui    312-926-3693    f-siddiqui2@northwestern.edu   
Principal Investigator: Maureen K Bolon, MD         
Sub-Investigator: Gary Noskins, MD         
United States, Iowa
University of Iowa Hospitals and Clinics Not yet recruiting
Iowa City, Iowa, United States, 52242-1081
Contact: Loreen Herwaldt, MD    319-356-0474    loreen-herwaldt@UIOWA.EDU   
Principal Investigator: Loreen Herwaldt, MD         
United States, Maryland
Johns Hopkins Hospital Not yet recruiting
Baltimore, Maryland, United States, 21205
Contact: Trish M Perl, MD, MSc    410-955-8384    tperl@jhmi.edu   
Contact: Kathleen Speck    (410) 614-6206    kspeck2@JHMI.EDU   
Principal Investigator: Trish M Perl, MD, MSc         
United States, Massachusetts
Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Debbie Yokoe, MD, MPH    617-525-2689    dyokoe@partners.org   
Principal Investigator: Debbie Yokoe, MD, MPH         
United States, Missouri
Barnes Jewish Hospital Not yet recruiting
St. Louis, Missouri, United States, 63110
Contact: Dave K Warren, MD       DWARREN@IM.WUSTL.EDU   
Contact: Liana Merz       lmerz@im.wustl.edu   
Principal Investigator: Dave K Warren, MD         
United States, New York
Memorial Sloan-Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10021
Contact: Kent A Sepkowitz, MD       sepkowik@MSKCC.ORG   
Contact: Kate Gase, MPH       gasek@MSKCC.ORG   
Principal Investigator: Kent A Sepkowitz, MD         
Sub-Investigator: Gianna Zucotti, MD         
United States, Virginia
Hunter Holmes McGuire Veteran Affairs Medical Center Recruiting
Richmond, Virginia, United States, 23249
Contact: Michael W Climo, MD    804-675-5018    michael.climo@va.gov   
Contact: Edward S Wong, MD    (804) 675-6792    edward.wong@va.gov   
Principal Investigator: Michael W Climo, MD         
Sub-Investigator: Edward S Wong, MD         
Sub-Investigator: Jane A Cecil, MD         
Sponsors and Collaborators
Hunter Holmes Mcguire Veteran Affairs Medical Center
Sage Products, Inc.
Investigators
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
Principal Investigator: Loreen Herwaldt, MD University of Iowa
  More Information

No publications provided by Hunter Holmes Mcguire Veteran Affairs Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00502476     History of Changes
Other Study ID Numbers: CI06-003
Study First Received: July 16, 2007
Last Updated: August 6, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Hunter Holmes Mcguire Veteran Affairs Medical Center:
MRSA
VRE
BSI

Additional relevant MeSH terms:
Bacteremia
Cross Infection
Staphylococcal Infections
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Gram-Positive Bacterial Infections
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on April 23, 2014