PneumoniaPhase 1NCT00841074
Chlorhexidine & Pneumonia in Nursing Home Residents
A Phase 1 study testing chlorhexidine in people with Pneumonia and Respiratory Infection, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Respiratory Infection
- What is being tested?
- chlorhexidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jul 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: 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.
- Conditions
- Pneumonia, Respiratory Infection
- Being tested
- chlorhexidine, Placebo mouthwash
- Keywords
- Pneumonia, Elderly, Chlorhexidine, Respiratory pathogens
- Medical subject headings
- Pneumonia, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlorhexidineDrug
Also called Peridex
0.12% chlorhexidine mouthwash spray, ~1.3 ml, twice a day.
Placebo mouthwashDrug
Also called Peridex mouthwash without chlorhexidine.
Placebo mouthwash spray application of ~1.3 ml twice a day.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Peridex mouthwash Receives: Drug: chlorhexidine |
| 2 | Placebo comparator | Placebo mouthwash Receives: Drug: Placebo mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumonia
Measured: 12 months
Secondary outcomes (2)
Respiratory pathogens
Measured: 12 months
Plaque and Gingival Indices
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startJan 2006
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Catherine J Binkley, University of Louisville
- Investigators
- Catherine J Binkley, DDS, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841074
- Sponsor's protocol ID
- OGMB040944
- Other IDs
- DE015760
- Status last verified
- Dec 2016
- First submitted
- 9 Feb 2009
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Oral Chlorhexidine in Reducing Pneumonia in Nursing Home Residents
- ClinicalTrials.gov ID
- NCT00841074
- Acronym / sponsor ID
- OGMB040944
- Conditions
- Pneumonia, Respiratory Infection
- Keywords
- Pneumonia, Elderly, Chlorhexidine, Respiratory pathogens
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Jan 2006
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 11 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: chlorhexidinePeridex mouthwash |
| 2 | Placebo comparator | Drug: Placebo mouthwashPlacebo mouthwash |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chlorhexidineAlso: Peridex0.12% chlorhexidine mouthwash spray, ~1.3 ml, twice a day. | Drug | 1 |
| Placebo mouthwashAlso: Peridex mouthwash without chlorhexidine.Placebo mouthwash spray application of ~1.3 ml twice a day. | Drug | 2 |
Primary outcome
Pneumonia
Time frame: 12 months
2 secondary outcomes
Respiratory pathogens
Time frame: 12 months
Plaque and Gingival Indices
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine J Binkley, DDS, PhD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing chlorhexidine in people with Pneumonia and Respiratory Infection, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pneumonia (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017.