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

Tracking Information

First Received Date ^ICMJE

February 9, 2009

Last Updated Date

August 6, 2009

Start Date ^ICMJE

January 2006

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pneumonia [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00841074 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Chlorhexidine & Pneumonia in Nursing Home Residents

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Pneumonia
Respiratory Infection

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: 1
Peridex mouthwash

Intervention: Drug: chlorhexidine
Placebo Comparator: 2
Placebo mouthwash

Intervention: Drug: Placebo mouthwash

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

December 2009

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

65 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00841074

Other Study ID Numbers ^ICMJE

OGMB040944, DE015760

Has Data Monitoring Committee

Yes

Responsible Party

Catherine J. Binkley, University of Louisville

Study Sponsor ^ICMJE

University of Louisville

Collaborators ^ICMJE

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators ^ICMJE

Principal Investigator:

Catherine J Binkley, DDS, PhD

University of Louisville

Information Provided By

University of Louisville

Verification Date

August 2009

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

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