Cost-Effectiveness Study Comparing Chlorhexidine Bathing With Active Surveillance Cultures to Prevent Methicillin-resistant Staphylococcus Aureus & Other Hospital Infections

Study Overview
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Brief Summary
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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).

Official Title
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Cost-Effectiveness of Chlorhexidine Bathing vs. Active Surveillance Cultures to Prevent Acquisition of Methicillin-resistant Staphylococcus Aureus and Other Hospital-Acquired Infections: A Pilot Study

Conditions
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Staphylococcal Infections

Intervention / Treatment
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* Other: Nasal swabs for MRSA culture
* Drug: Chlorhexidine gluconate
* Other: Contact isolation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients admitted to the medical intensive care unit (ICU) are eligible for inclusion Exclusion Criteria: Patient refusal Contraindication to nasal swabbing (arm 1) Allergy/sensitivity to chlorhexidine gluconate (CHG) (arm 2)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Active surveillance cultures (ASC) (via nasal swabs) will be performed for all patients admitted to the medical intensive care unit (ICU) during the designated study period. All patients will be placed in contact isolation until nasal swabs return negative; otherwise will remain in isolation. | Other: Nasal swabs for MRSA culture<br>* Patients will have nasal swabs performed upon ICU admission, upon discharge, and every 2 weeks while they remain in the ICU.<br>Other: Contact isolation<br>* All patients will be placed in contact isolation until the results of their active surveillance cultures are negative; if positive, they will remain in isolation.<br>|
| Active Comparator: 2<br>Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures (ASC) will also be used in this arm, but results will be blinded and not used to determine whether patients should be in contact isolation. | Other: Nasal swabs for MRSA culture<br>* Patients will have nasal swabs performed upon ICU admission, upon discharge, and every 2 weeks while they remain in the ICU.<br>Drug: Chlorhexidine gluconate<br>* CHG-impregnated cloths (2%) will be used to bathe patients at least daily during the duration of their medical ICU stay. Surveillance cultures will be obtained on admission, discharge and every 2 weeks while in the ICU, but results will be blinded until conclusion of the study.<br>* Other names: Sage 2% Chlorhexidine gluconate cloth;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acquisition of Methicillin-resistant Staph Aureus (MRSA) Colonization or Infection | Number of patients who acquired MRSA by the time of ICU discharge (based on nasal swab or clinical culture). | During ICU stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Central Line Associated Bloodstream Infection |  | During ICU stay up to six months | 
| Vancomycin Resistant Enterococcal Infection or Colonization |  | During ICU stay | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methicillin resistance, Infection control, Staphylococcus aureus, Cross infection, Epidemiology, Chlorhexidine