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

NCT00779246 | Completed Results

• 1 other identifier: 28116
• Study Type: interventional
• Target: 1,518
• Locations: 1 country
• Sites: 1

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).

Conditions

Staphylococcal Infections

Keywords

Methicillin resistance; Infection control; Staphylococcus aureus; Cross infection; Epidemiology; Chlorhexidine

Outcome Measures

Primary Outcomes (1)

• 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).

  During ICU stay

Secondary Outcomes (2)

• Number of Participants With Central Line Associated Bloodstream Infection

  During ICU stay up to six months

• Vancomycin Resistant Enterococcal Infection or Colonization

  During ICU stay

Study Arms (2)

1

ACTIVE COMPARATOR

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; Other: Contact isolation

2

ACTIVE COMPARATOR

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; Drug: Chlorhexidine gluconate

Interventions

Nasal swabs for MRSA culture OTHER

Patients will have nasal swabs performed upon ICU admission, upon discharge, and every 2 weeks while they remain in the ICU.

1; 2

Chlorhexidine gluconate DRUG

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.

Also known as: Sage 2% Chlorhexidine gluconate cloth

2

Contact isolation OTHER

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Christiana Care Health Services: lead
• Sage Products, Inc.: collaborator

Study Sites (1)

Christiana Hospital

Newark, Delaware, 19718, United States

Location

MeSH Terms

Conditions

Staphylococcal Infections; Cross Infection

Interventions

chlorhexidine gluconate; Quarantine

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Limitations and Caveats

* Single-center, single-unit study limits generalizability * MRSA acquisition rates lower during both intervention groups than expected, resulting in under-powering of study * Baseline rate of acquisition of colonization unknown

Results Point of Contact

• Title: Marci Drees, MD, MS
• Organization: Christiana Care Health System

mdrees@christianacare.org

302-733-5602

Study Officials

• Marci Drees, MD, MS

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: October 24, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: May 15, 2018
• Results First Posted: March 21, 2012

Record last verified: 2018-04

Locations

US (1)