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Sponsors and Collaborators: |
Christiana Care Health Services Sage Products, Inc. |
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Information provided by: | Christiana Care Health Services |
ClinicalTrials.gov Identifier: | NCT00779246 |
This pilot study in our medical intensive care unit will evaluate the clinical and cost-effectiveness of an active surveillance program for methicillin-resistant Staphylococcus aureus (MRSA), compared to routine daily bathing with chlorhexidine gluconate (CHG)-impregnated cloths. Outcomes include rate of MRSA acquisition, and of other hospital-acquired infections (e.g., catheter-associated bloodstream infections).
Condition | Intervention | Phase |
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Staphylococcal Infections |
Other: Nasal swabs for MRSA culture Drug: Chlorhexidine gluconate |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Factorial Assignment, Efficacy Study |
Official Title: | Cost-Effectiveness of Chlorhexidine Bathing vs. Active Surveillance Cultures to Prevent Acquisition of MRSA and Other Hospital-Acquired Infections: A Pilot Study |
Estimated Enrollment: | 1300 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period.
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Other: Nasal swabs for MRSA culture
Patients will have nasal swabs performed upon ICU admission, upon discharge, and every 2 weeks while they remain in the ICU.
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2: Active Comparator
Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water.
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Drug: Chlorhexidine gluconate
CHG-impregnated cloths (2%) will be used to bathe patients at least daily during the duration of their medical ICU stay.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Delaware | |
Christiana Hospital | Recruiting |
Newark, Delaware, United States, 19718 | |
Contact: Marci Drees, MD, MS 302-623-0691 mdrees@christianacare.org | |
Contact: Patty McGraw, RN, MS pmcgraw@christianacare.org | |
Principal Investigator: Marci Drees, MD, MS |
Principal Investigator: | Marci Drees, MD, MS | Christiana Care Health Services |
Responsible Party: | Christiana Care Health Services ( Marci Drees, MD, MS ) |
Study ID Numbers: | 28116 |
Study First Received: | October 22, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00779246 |
Health Authority: | United States: Food and Drug Administration |
Methicillin resistance Infection control Staphylococcus aureus |
Cross infection Epidemiology Chlorhexidine |
Bacterial Infections Staphylococcal Infections Gram-Positive Bacterial Infections Methicillin |
Chlorhexidine Chlorhexidine gluconate Cross Infection |
Anti-Infective Agents Anti-Infective Agents, Local Communicable Diseases Disinfectants |
Therapeutic Uses Infection Dermatologic Agents Pharmacologic Actions |