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Chlorhexidine & Pneumonia in Nursing Home Residents

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by University of Louisville.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:
University of Louisville
ClinicalTrials.gov Identifier:
NCT00841074
First received: February 9, 2009
Last updated: August 6, 2009
Last verified: August 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Pneumonia [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Respiratory pathogens [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Plaque and Gingival Indices [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: January 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: July 2009 (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
Genders Eligible for Study:   Both
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
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

No publications provided

Responsible Party: Catherine J. Binkley, University of Louisville
ClinicalTrials.gov Identifier: NCT00841074     History of Changes
Other Study ID Numbers: OGMB040944, DE015760
Study First Received: February 9, 2009
Last Updated: August 6, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on May 21, 2013