search
Back to results

Chlorhexidine & Pneumonia in Nursing Home Residents

Primary Purpose

Pneumonia, Respiratory Infection

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
chlorhexidine
Placebo mouthwash
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumonia focused on measuring Pneumonia, Elderly, Chlorhexidine, Respiratory pathogens

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts 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.

Sites / Locations

  • University of Louisville

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Peridex mouthwash

Placebo mouthwash

Outcomes

Primary Outcome Measures

Pneumonia

Secondary Outcome Measures

Respiratory pathogens
Plaque and Gingival Indices

Full Information

First Posted
February 9, 2009
Last Updated
April 12, 2017
Sponsor
University of Louisville
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
search

1. Study Identification

Unique Protocol Identification Number
NCT00841074
Brief Title
Chlorhexidine & Pneumonia in Nursing Home Residents
Official Title
Effect of Topical Oral Chlorhexidine in Reducing Pneumonia in Nursing Home Residents
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Respiratory Infection
Keywords
Pneumonia, Elderly, Chlorhexidine, Respiratory pathogens

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Peridex mouthwash
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo mouthwash
Intervention Type
Drug
Intervention Name(s)
chlorhexidine
Other Intervention Name(s)
Peridex
Intervention Description
0.12% chlorhexidine mouthwash spray, ~1.3 ml, twice a day.
Intervention Type
Drug
Intervention Name(s)
Placebo mouthwash
Other Intervention Name(s)
Peridex mouthwash without chlorhexidine.
Intervention Description
Placebo mouthwash spray application of ~1.3 ml twice a day.
Primary Outcome Measure Information:
Title
Pneumonia
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Respiratory pathogens
Time Frame
12 months
Title
Plaque and Gingival Indices
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants must be at least 65 years old. 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. Have natural teeth and/or wear complete or partial dentures. Expected to be a resident in a nursing home for two years. Exclusion Criteria: Existing pneumonia. History of chlorhexidine reaction or allergy and/or multiple medication or substance allergies. Receiving chlorhexidine oral application at enrollment as prescribed by physician or dentist.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine J Binkley, DDS, PhD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Chlorhexidine & Pneumonia in Nursing Home Residents

We'll reach out to this number within 24 hrs