Cost-Effectiveness Study Comparing Chlorhexidine Bathing With Active Surveillance Cultures to Prevent MRSA & Other Hospital Infections - Tabular View

Tracking Information

First Received Date ^ICMJE

October 22, 2008

Last Updated Date

September 17, 2009

Start Date ^ICMJE

June 2008

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Acquisition of MRSA colonization or infection [ Time Frame: During ICU stay ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00779246 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Central line associated bloodstream infection [ Time Frame: During ICU stay ] [ Designated as safety issue: Yes ]
Vancomycin resistant enterococcal infection or colonization [ Time Frame: During ICU stay ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Cost-Effectiveness Study Comparing Chlorhexidine Bathing With Active Surveillance Cultures to Prevent MRSA & Other Hospital Infections

Official Title ^ICMJE

Cost-Effectiveness of Chlorhexidine Bathing vs. Active Surveillance Cultures to Prevent Acquisition of MRSA and Other Hospital-Acquired Infections: A Pilot Study

Brief 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).

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Open Label, Factorial Assignment, Efficacy Study

Condition ^ICMJE

Staphylococcal Infections

Intervention ^ICMJE

Other: Nasal swabs for MRSA culture
Drug: Chlorhexidine gluconate

Study Arms / Comparison Groups

Active Comparator: Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period.
Active Comparator: Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

1300

Estimated Completion Date

July 2010

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

All patients admitted to the medical ICU are eligible for inclusion

Exclusion Criteria:

Patient refusal
Contraindication to nasal swabbing (arm 1)
Allergy/sensitivity to CHG (arm 2)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00779246

Responsible Party

Marci Drees, MD, MS, Christiana Care Health Services

Study ID Numbers ^ICMJE

28116

Study Sponsor ^ICMJE

Christiana Care Health Services

Collaborators ^ICMJE

Sage Products, Inc.

Investigators ^ICMJE

Principal Investigator:

Marci Drees, MD, MS

Christiana Care Health Services

Information Provided By

Christiana Care Health Services

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP