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

Staphylococcal Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00779246
• Other study ID #: 28116
• Status: Completed
• Phase: N/A
• Start date: June 2008
• Est. completion date: July 2009

Study information

• Verified date: April 2018
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1518
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Staphylococcal Infections

Intervention

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.

Locations

Country	Name	City	State
United States	Christiana Hospital	Newark	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Christiana Care Health Services	Sage Products, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Central Line Associated Bloodstream Infection		During ICU stay up to six months
Secondary	Vancomycin Resistant Enterococcal Infection or Colonization		During ICU stay