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

Overview

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).

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2009

Interventions

  • 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.
  • Drug: Chlorhexidine gluconate
    • 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.
  • Other: Contact isolation
    • 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.

Arms, Groups and Cohorts

  • Active Comparator: 1
    • 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.
  • Active Comparator: 2
    • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Number of Participants With Central Line Associated Bloodstream Infection
    • Time Frame: During ICU stay up to six months
  • Vancomycin Resistant Enterococcal Infection or Colonization
    • Time Frame: During ICU stay

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Christiana Care Health Services
  • Collaborator
    • Sage Products, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marci Drees, MD, MS, Principal Investigator, Christiana Care Health Services

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