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| Sponsors and Collaborators: |
Christiana Care Health Services Sage Products, Inc. |
|---|---|
| Information provided by: | Christiana Care Health Services |
| ClinicalTrials.gov Identifier: | NCT00779246 |
Purpose
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 |
|---|---|---|
|
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 |
|---|---|
|
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.
|
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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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| 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 |
More Information
| 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 |
