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Completed

NCT Number: NCT00779246

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christiana Hospital

Newark, Delaware, 19718, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Other names: Sage 2% Chlorhexidine gluconate cloth

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Collaborators

  • Sage Products, Inc.

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 24, 2008
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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