Pneumonia, Respiratory Infection
Conditions
Keywords
Pneumonia, Elderly, Chlorhexidine, Respiratory pathogens
Brief summary
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.
Interventions
DRUGchlorhexidine
0.12% chlorhexidine mouthwash spray, \ 1.3 ml, twice a day.
DRUGPlacebo mouthwash
Placebo mouthwash spray application of \ 1.3 ml twice a day.
Sponsors
National Institute of Dental and Craniofacial Research (NIDCR)
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pneumonia | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Respiratory pathogens | 12 months |
| Plaque and Gingival Indices | 12 months |
Countries
United States
Outcome results
None listed