Chlorhexidine & Pneumonia in Nursing Home Residents

NCT ID: NCT00841074

Last Updated: 2017-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2011-07-31

Brief Summary

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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

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Conditions

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Pneumonia Respiratory Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Peridex mouthwash

Group Type EXPERIMENTAL

chlorhexidine

Intervention Type DRUG

0.12% chlorhexidine mouthwash spray, \~1.3 ml, twice a day.

2

Placebo mouthwash

Group Type PLACEBO_COMPARATOR

Placebo mouthwash

Intervention Type DRUG

Placebo mouthwash spray application of \~1.3 ml twice a day.

Interventions

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chlorhexidine

0.12% chlorhexidine mouthwash spray, \~1.3 ml, twice a day.

Intervention Type DRUG

Placebo mouthwash

Placebo mouthwash spray application of \~1.3 ml twice a day.

Intervention Type DRUG

Other Intervention Names

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Peridex Peridex mouthwash without chlorhexidine.

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role collaborator

University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Catherine J Binkley

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Catherine J Binkley, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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University of Louisville

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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DE015760

Identifier Type: -

Identifier Source: secondary_id

OGMB040944

Identifier Type: -

Identifier Source: org_study_id

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