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

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ClinicalTrials.gov Identifier: NCT00779246
Recruitment Status : Completed
First Posted : October 24, 2008
Results First Posted : March 21, 2012
Last Update Posted : May 15, 2018
Sponsor:
Collaborator:
Sage Products, Inc.
Information provided by (Responsible Party):
Christiana Care Health Services

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).

Condition or disease Intervention/treatment Phase
Staphylococcal Infections Other: Nasal swabs for MRSA culture Drug: Chlorhexidine gluconate Other: Contact isolation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1518 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of Participants With Central Line Associated Bloodstream Infection [ Time Frame: During ICU stay up to six months ]
  2. Vancomycin Resistant Enterococcal Infection or Colonization [ Time Frame: During ICU stay ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT00779246     History of Changes
Other Study ID Numbers: 28116
First Posted: October 24, 2008    Key Record Dates
Results First Posted: March 21, 2012
Last Update Posted: May 15, 2018
Last Verified: April 2018

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Chlorhexidine
Chlorhexidine gluconate
Methicillin
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Anti-Bacterial Agents