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| Sponsors and Collaborators: |
Hunter Holmes Mcguire Veteran Affairs Medical Center Centers for Disease Control and Prevention Sage Products, Inc. |
|---|---|
| Information provided by: | Hunter Holmes Mcguire Veteran Affairs Medical Center |
| ClinicalTrials.gov Identifier: | NCT00502476 |
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: | Natural History, Longitudinal, Defined Population, Prospective Study |
| Official Title: | Multicenter Evaluation of The Effectiveness of Source Control With Daily Chlorhexidine Skin Preparation in Reducing Nosocomial Infections Including MRSA and VRE |
| Estimated Enrollment: | 14000 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | September 2009 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Michael W Climo, MD | (804) 675-5018 | michael.climo@va.gov |
| Contact: Edward S Wong, MD | (804) 675-6792 | edward.wong@va.gov |
| 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 | |
| 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
| Study ID Numbers: | CI06-003 |
| Study First Received: | July 16, 2007 |
| Last Updated: | August 6, 2007 |
| ClinicalTrials.gov Identifier: | NCT00502476 |
| Health Authority: | United States: Food and Drug Administration |
|
MRSA VRE BSI |
|
Systemic Inflammatory Response Syndrome Bacterial Infections Sepsis Chlorhexidine |
Chlorhexidine gluconate Bacteremia Cross Infection Inflammation |
|
Anti-Infective Agents Anti-Infective Agents, Local Communicable Diseases Disinfectants Pathologic Processes |
Therapeutic Uses Infection Dermatologic Agents Pharmacologic Actions |
