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

• 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: Christiana Care Health Services
• Collaborator: Sage Products, Inc.
• Information provided by (Responsible Party): Christiana Care Health Services

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).

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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)

Contacts and Locations

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

• Responsible Party: Christiana Care Health Services
• ClinicalTrials.gov Identifier: NCT00779246
• Other Study ID Numbers: 28116
• First Posted: October 24, 2008
• 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:

Infections; Communicable Diseases; Staphylococcal Infections; Disease Attributes; Pathologic Processes; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Chlorhexidine; Chlorhexidine gluconate; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Dermatologic Agents