This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Chlorhexidine & Pneumonia in Nursing Home Residents

This study has been completed.
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Catherine J Binkley, University of Louisville
ClinicalTrials.gov Identifier:
NCT00841074
First received: February 9, 2009
Last updated: April 12, 2017
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
Pneumonia Respiratory Infection Drug: chlorhexidine Drug: Placebo mouthwash Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Topical Oral Chlorhexidine in Reducing Pneumonia in Nursing Home Residents

Resource links provided by NLM:


Further study details as provided by Catherine J Binkley, University of Louisville:

Primary Outcome Measures:
  • Pneumonia [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Respiratory pathogens [ Time Frame: 12 months ]
  • Plaque and Gingival Indices [ Time Frame: 12 months ]

Enrollment: 75
Study Start Date: January 2006
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Peridex mouthwash
Drug: chlorhexidine
0.12% chlorhexidine mouthwash spray, ~1.3 ml, twice a day.
Other Name: Peridex
Placebo Comparator: 2
Placebo mouthwash
Drug: Placebo mouthwash
Placebo mouthwash spray application of ~1.3 ml twice a day.
Other Name: Peridex mouthwash without chlorhexidine.

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841074

Locations
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Catherine J Binkley, DDS, PhD University of Louisville
  More Information

Responsible Party: Catherine J Binkley, PI, University of Louisville
ClinicalTrials.gov Identifier: NCT00841074     History of Changes
Other Study ID Numbers: OGMB040944
DE015760
Study First Received: February 9, 2009
Last Updated: April 12, 2017

Keywords provided by Catherine J Binkley, University of Louisville:
Pneumonia
Elderly
Chlorhexidine
Respiratory pathogens

Additional relevant MeSH terms:
Pneumonia
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Infection
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on September 19, 2017