Chlorhexidine & Pneumonia in Nursing Home Residents

Phase 1

Completed

• Conditions: Pneumonia; Respiratory Infection
• Interventions: Drug: Placebo mouthwash; Drug: chlorhexidine

• Registration Number: NCT00841074
• Lead Sponsor: University of Louisville

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2009-02-09
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-11
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2016-12
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo mouthwash	Placebo mouthwash
1	chlorhexidine	Peridex mouthwash

Primary Outcome Measures

Name	Time	Method
Pneumonia	12 months

Secondary Outcome Measures

Name	Time	Method
Plaque and Gingival Indices	12 months
Respiratory pathogens	12 months

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States