Chlorhexidine & Pneumonia in Nursing Home Residents

April 12, 2017 updated by: Catherine J Binkley, University of Louisville

Effect of Topical Oral Chlorhexidine in Reducing Pneumonia in Nursing Home Residents

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Peridex mouthwash
Drug: chlorhexidine
0.12% chlorhexidine mouthwash spray, ~1.3 ml, twice a day.
Other Names:
  • Peridex
Placebo Comparator: 2
Placebo mouthwash
Drug: Placebo mouthwash
Placebo mouthwash spray application of ~1.3 ml twice a day.
Other Names:
  • Peridex mouthwash without chlorhexidine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pneumonia
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Respiratory pathogens
Time Frame: 12 months
12 months
Plaque and Gingival Indices
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

  • Principal Investigator: Catherine J Binkley, DDS, PhD, University of Louisville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

February 9, 2009

First Submitted That Met QC Criteria

February 10, 2009

First Posted (Estimate)

February 11, 2009

Study Record Updates

Last Update Posted (Actual)

April 14, 2017

Last Update Submitted That Met QC Criteria

April 12, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OGMB040944
  • DE015760

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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