NCT00841074

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

April 14, 2017

Status Verified

December 1, 2016

Enrollment Period

5.5 years

First QC Date

February 9, 2009

Last Update Submit

April 12, 2017

Conditions

PneumoniaRespiratory Infection

Keywords

PneumoniaElderlyChlorhexidineRespiratory pathogens

Outcome Measures

Primary Outcomes (1)

  • Pneumonia

    12 months

Secondary Outcomes (2)

  • Respiratory pathogens

    12 months

  • Plaque and Gingival Indices

    12 months

Study Arms (2)

1

EXPERIMENTAL

Peridex mouthwash

Drug: chlorhexidine

2

PLACEBO COMPARATOR

Placebo mouthwash

Drug: Placebo mouthwash

Interventions

chlorhexidineDRUG

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

Also known as: Peridex
1
Placebo mouthwashDRUG

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

Also known as: Peridex mouthwash without chlorhexidine.
2

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

PneumoniaRespiratory Tract Infections

Interventions

Chlorhexidinechlorhexidine gluconate

Condition Hierarchy (Ancestors)

InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Catherine J Binkley, DDS, PhD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

February 9, 2009

First Posted

February 11, 2009

Study Start

January 1, 2006

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

April 14, 2017

Record last verified: 2016-12

Locations

US(1)