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Completed

NCT Number: NCT00841074

Chlorhexidine & 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.

Completed

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Infection Respiratory Tract Diseases Respiratory Tract Infections

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Louisville

Louisville, Kentucky, 40202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chlorhexidine

Drug

0.12% chlorhexidine mouthwash spray, ~1.3 ml, twice a day.

Other names: Peridex

Placebo Mouthwash

Drug

Placebo mouthwash spray application of ~1.3 ml twice a day.

Other names: Peridex mouthwash without chlorhexidine.

Primary outcomes

  1. Pneumonia

    Time frame: 12 months

Secondary outcomes

  1. Respiratory pathogens

    Time frame: 12 months

  2. Plaque and Gingival Indices

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Feb 11, 2009
Registry last updated
Apr 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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