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NCT00841074 Clinical Trial

Chlorhexidine & Pneumonia in Nursing Home Residents

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00841074
Other study ID # OGMB040944
Secondary ID DE015760
Status Completed
Phase Phase 1
First received February 9, 2009
Last updated April 12, 2017
Start date January 2006
Est. completion date July 2011

Study information
Verified date December 2016
Source University of Louisville
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• chlorhexidine
0.12% chlorhexidine mouthwash spray, ~1.3 ml, twice a day.
• Placebo mouthwash
Placebo mouthwash spray application of ~1.3 ml twice a day.

Locations
Country Name City State
United States University of Louisville Louisville Kentucky

Sponsors (2)
Lead Sponsor Collaborator
University of Louisville National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pneumonia 12 months
Secondary Respiratory pathogens 12 months
Secondary Plaque and Gingival Indices 12 months
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