PneumoniaPhase 3PRIDENCT00975780

A Trial to Reduce Pneumonia in Nursing Home Residents

A Phase 3 study testing Enhanced Oral Care and Usual oral care in people with Pneumonia and Lower Respiratory Tract Infection, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to test the effectiveness of an enhanced oral hygiene protocol in preventing pneumonia among nursing home residents. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Pneumonia, Lower Respiratory Tract Infection
What is being tested?: Enhanced Oral Care and Usual oral care
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 834 participants
Where: 1 siteUnited States
Study dates: Oct 2009to Dec 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Older adult

Who may be able to join

long term care resident of nursing home
residents age >65
residents of nursing home for at least one month
residents having at least one of two modifiable risk factors for pneumonia (i.e., impaired oral hygiene, swallowing difficulty)

Who cannot join

residents housed in nursing home for short term rehabilitation
residents who receive nourishment by tube feeding
residents who have a life expectancy < 3 months
residents who have been diagnosed with pneumonia within the previous 6 weeks
residents who are currently using oral chlorhexidine
residents who have previously been enrolled in the study

Show all 10Show fewer

residents, or their designated proxies, who are unwilling to give informed consent
residents who have tracheostomy
residents who are non-english speaking
residents who the administrator leadership of the home felt were not appropriate for the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale University School of Medicine
New Haven, Connecticut, 06520

Other trials in United States

About this study

Official title: A Randomized Controlled Trial to Reduce Pneumonia in Nursing Home Residents

The purpose of this study is to test the effectiveness of an enhanced oral hygiene protocol in preventing pneumonia among nursing home residents.

Conditions: Pneumonia, Lower Respiratory Tract Infection
Being tested: Enhanced Oral Care, Usual oral care
Keywords: Pneumonia, Lower respiratory tract infection, Lower respiratory tract infection other than pneumonia
Medical subject headings: Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enhanced Oral CareOther
oral brushing plus oral chlorhexidine plus upright feeding positioning
Usual oral careOther
Usual oral care and feeding positioning

Study groups in NCT00975780
Study group	Role	What they receive
enhanced oral care	Experimental	Not described Receives: Other: Enhanced Oral Care
Usual care	Active comparator	The usual oral care provided at the nursing home Receives: Other: Usual oral care

What is being measured

The primary outcome is the main question the study is designed to answer.

Pneumonia
The number of participants that recorded a 'first pneumonia' during the 2.5 years timeframe.
Measured: 2.5 years

Secondary outcomes (1)

Lower Respiratory Tract Infection Other Than Pneumonia
The number of participants that recorded a 'lower respiratory tract infection other than pneumonia' during the 2.5 years timeframe.
Measured: 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Dec 2012

First posted11 Sep 2009 (estimated)
Study startOct 2009
Primary completionDec 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PneumoniaStudies of the same condition, open and under way.
More trials run by Yale UniversityThe 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 834 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00975780
Sponsor's protocol ID: 0609001783
Other IDs: R01AG030575
Acronym: PRIDE
Status last verified: Nov 2014
First submitted: 10 Sep 2009
Last updated: 20 Nov 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Juthani-Mehta M, Van Ness PH, McGloin J, Argraves S, Chen S, Charpentier P, Miller L, Williams K, Wall D, Baker D, Tinetti M, Peduzzi P, Quagliarello VJ. A cluster-randomized controlled trial of a multicomponent intervention protocol for pneumonia prevention among nursing home elders. Clin Infect Dis. 2015 Mar 15;60(6):849-57. doi: 10.1093/cid/ciu935. Epub 2014 Dec 16.
PubMed 25520333

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial to Reduce Pneumonia in Nursing Home Residents
ClinicalTrials.gov ID: NCT00975780
Acronym / sponsor ID: PRIDE / 0609001783
Conditions: Pneumonia, Lower Respiratory Tract Infection
Keywords: Pneumonia, Lower respiratory tract infection, Lower respiratory tract infection other than pneumonia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 834 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: Oct 2009
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 11 Sep 2009 (estimated)
Results: Posted 21 Jan 2014

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 to test the effectiveness of an enhanced oral hygiene protocol in preventing pneumonia among nursing home residents.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
enhanced oral care	Experimental	Other: Enhanced Oral Care
Usual care	Active comparator	Other: Usual oral careThe usual oral care provided at the nursing home

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (4 listed)

long term care resident of nursing home
residents age >65
residents of nursing home for at least one month
residents having at least one of two modifiable risk factors for pneumonia (i.e., impaired oral hygiene, swallowing difficulty)

Key exclusion criteria (10 listed)

residents housed in nursing home for short term rehabilitation
residents who receive nourishment by tube feeding
residents who have a life expectancy < 3 months
residents who have been diagnosed with pneumonia within the previous 6 weeks
residents who are currently using oral chlorhexidine

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
Enhanced Oral Careoral brushing plus oral chlorhexidine plus upright feeding positioning	Other	enhanced oral care
Usual oral careUsual oral care and feeding positioning	Other	Usual care

Primary outcome

Pneumonia
Time frame: 2.5 years
The number of participants that recorded a 'first pneumonia' during the 2.5 years timeframe.

1 secondary outcome

Lower Respiratory Tract Infection Other Than Pneumonia
Time frame: 2.5 years

Results and safety

Results posted to the registry on 21 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	400	400
Enhanced Oral Care	434	434

Primary outcome: Pneumonia

Time frame: 2.5 years. Number. Unit: participants

Measure	Enhanced Oral Care n = 434	Usual Oral Care n = 400
Value	119	94

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events (both Serious and Other) were collected over the 2.5 year study period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enhanced Oral Care	204 of 434 (47%)	391 of 434 (90.1%)	Not reported
Usual Oral Care	153 of 400 (38.3%)	371 of 400 (92.8%)	Not reported

Limitations and caveats (from the sponsor): Participant flow and outcome information pertains to data collected through 10/25/2012- the official trial termination date. Serious and Other Adverse Event information pertains to requested surveillance of subjects through 12/10/2012 per the NIA.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25520333Juthani-Mehta M, Van Ness PH, McGloin J, Argraves S, Chen S, Charpentier P, Miller L, Williams K, Wall D, Baker D, Tinetti M, Peduzzi P, Quagliarello VJ. A cluster-randomized controlled trial of a multicomponent intervention protocol for pneumonia prevention among nursing home elders. Clin Infect Dis. 2015 Mar 15;60(6):849-57. doi: 10.1093/cid/ciu935. Epub 2014 Dec 16.

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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.

Vincent J Quagliarello, MD principal investigator

Yale University

Mary Tinetti, MD study director

Yale University

Manisha Juthani-Mehta, MD study director

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Enhanced Oral Care and Usual oral care in people with Pneumonia and Lower Respiratory Tract Infection, run by Yale University 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 10 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 20 Nov 2014. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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: 2.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00975780, which also lists 1 linked publication.

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 20 Nov 2014.