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

Primary Purpose

Staphylococcal Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nasal swabs for MRSA culture
Chlorhexidine gluconate
Contact isolation
Sponsored by
Christiana Care Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Staphylococcal Infections focused on measuring Methicillin resistance, Infection control, Staphylococcus aureus, Cross infection, Epidemiology, Chlorhexidine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Christiana Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Number of Participants With Central Line Associated Bloodstream Infection
Vancomycin Resistant Enterococcal Infection or Colonization

Full Information

First Posted
October 22, 2008
Last Updated
April 16, 2018
Sponsor
Christiana Care Health Services
Collaborators
Sage Products, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00779246
Brief Title
Cost-Effectiveness Study Comparing Chlorhexidine Bathing With Active Surveillance Cultures to Prevent Methicillin-resistant Staphylococcus Aureus & Other Hospital Infections
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Christiana Care Health Services
Collaborators
Sage Products, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcal Infections
Keywords
Methicillin resistance, Infection control, Staphylococcus aureus, Cross infection, Epidemiology, Chlorhexidine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1518 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Nasal swabs for MRSA culture
Intervention Description
Patients will have nasal swabs performed upon ICU admission, upon discharge, and every 2 weeks while they remain in the ICU.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate
Other Intervention Name(s)
Sage 2% Chlorhexidine gluconate cloth
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Contact isolation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acquisition of Methicillin-resistant Staph Aureus (MRSA) Colonization or Infection
Description
Number of patients who acquired MRSA by the time of ICU discharge (based on nasal swab or clinical culture).
Time Frame
During ICU stay
Secondary Outcome Measure Information:
Title
Number of Participants With Central Line Associated Bloodstream Infection
Time Frame
During ICU stay up to six months
Title
Vancomycin Resistant Enterococcal Infection or Colonization
Time Frame
During ICU stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marci Drees, MD, MS
Organizational Affiliation
Christiana Care Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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