Chlorhexidine & Pneumonia in Nursing Home Residents

University of Louisville (UOFL)

Status and phase: Completed; Phase 1

Conditions: Pneumonia; Respiratory Infection

Treatments: Drug: Placebo mouthwash; Drug: chlorhexidine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00841074

DE015760

OGMB040944

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Peridex mouthwash

Treatment:

Drug: chlorhexidine

2

Placebo Comparator group

Description:

Placebo mouthwash

Treatment:

Drug: Placebo mouthwash