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

This study has been completed.
Sponsor:
Collaborator:
Sage Products, Inc.
Information provided by (Responsible Party):
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00779246
First received: October 22, 2008
Last updated: February 16, 2012
Last verified: February 2012
History of Changes
  Purpose

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).


Condition Intervention
Staphylococcal Infections
 Other: Nasal swabs for MRSA culture
Drug: Chlorhexidine gluconate
Other: Contact isolation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Acquisition of Methicillin-resistant Staph Aureus (MRSA) Colonization or Infection [ Time Frame: During ICU stay ] [ Designated as safety issue: Yes ]
    Number of patients who acquired MRSA by the time of ICU discharge (based on nasal swab or clinical culture).


Secondary Outcome Measures:
  • 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 ]

Enrollment: 1518
Study Start Date: June 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
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.
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.
 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 Name: Sage 2% Chlorhexidine gluconate cloth

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00779246

Locations
United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Sage Products, Inc.
Investigators
Principal Investigator: Marci Drees, MD, MS Christiana Care Health Services
  More Information

No publications provided

Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT00779246     History of Changes
Other Study ID Numbers: 28116
Study First Received: October 22, 2008
Results First Received: August 1, 2011
Last Updated: February 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Christiana Care Health Services:
Methicillin resistance
Infection control
Staphylococcus aureus
 Cross infection
Epidemiology
Chlorhexidine

Additional relevant MeSH terms:
Staphylococcal Infections
Cross Infection
Gram-Positive Bacterial Infections
Bacterial Infections
Infection
Chlorhexidine
Chlorhexidine gluconate
Methicillin
 Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 19, 2013