Chlorhexidine & Pneumonia in Nursing Home Residents

Condition(s) targeted: Pneumonia; Respiratory Infection

Intervention: chlorhexidine (Drug); Placebo mouthwash (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: University of Louisville

Official(s) and/or principal investigator(s):
Catherine J Binkley, DDS, PhD, Principal Investigator, Affiliation: University of Louisville

The purpose of this study is determine if topical oral application of a chlorhexidine antimicrobial spray will significantly reduce pneumonia and respiratory infections, and improve oral health compared to a placebo solution in nursing home residents.

Official title: Effect of Topical Oral Chlorhexidine in Reducing Pneumonia in Nursing Home Residents

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Pneumonia

Secondary outcome:

Respiratory pathogens

Plaque and Gingival Indices

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Participants must be at least 65 years old. 2. Be dependent in 2 or more Activities of Daily Living as noted on the nursing home

resident's Minimum Data Set - One must be ADL J- Personal Hygiene.

3. Have natural teeth and/or wear complete or partial dentures. 4. Expected to be a resident in a nursing home for two years. Exclusion Criteria: 1. Existing pneumonia. 2. History of chlorhexidine reaction or allergy and/or multiple medication or substance allergies. 3. Receiving chlorhexidine oral application at enrollment as prescribed by physician or dentist.

University of Louisville, Louisville, Kentucky 40202, United States

Starting date: January 2006
Last updated: August 6, 2009