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Chlorhexidine & Pneumonia in Nursing Home Residents

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ClinicalTrials.gov Identifier: NCT00841074
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : April 14, 2017
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Catherine J Binkley, University of Louisville

February 9, 2009
February 11, 2009
April 14, 2017
January 2006
July 2011   (Final data collection date for primary outcome measure)
Pneumonia [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT00841074 on ClinicalTrials.gov Archive Site
  • Respiratory pathogens [ Time Frame: 12 months ]
  • Plaque and Gingival Indices [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
 
Chlorhexidine & Pneumonia in Nursing Home Residents
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Pneumonia
  • Respiratory Infection
  • Drug: chlorhexidine
    0.12% chlorhexidine mouthwash spray, ~1.3 ml, twice a day.
    Other Name: Peridex
  • Drug: Placebo mouthwash
    Placebo mouthwash spray application of ~1.3 ml twice a day.
    Other Name: Peridex mouthwash without chlorhexidine.
  • Experimental: 1
    Peridex mouthwash
    Intervention: Drug: chlorhexidine
  • Placebo Comparator: 2
    Placebo mouthwash
    Intervention: Drug: Placebo mouthwash
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
Same as current
July 2011
July 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
65 Years and older   (Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00841074
OGMB040944
DE015760
Yes
Not Provided
Not Provided
Catherine J Binkley, University of Louisville
University of Louisville
National Institute of Dental and Craniofacial Research (NIDCR)
Principal Investigator: Catherine J Binkley, DDS, PhD University of Louisville
University of Louisville
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP