PneumoniaNCT01403805

Effects of the Oral Care With Vaccines for Pneumonia in Elderly; Going Home Together Both Physician and Dentist

A study testing Pneumococcal vaccination (Pneumovax NP, 21800AMY10131000), Influenza vaccination (Flubik HA, 16100EZZ01207000) and Specific frequency of oral care in people with Pneumonia, run by Yubari Kibounomori at 1 site in Japan.

Completed

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

Official record

Search all trials

Trial summary

Prospective study comparing the effects of interventions (combined oral care and pneumococcal plus influenza vaccinations) in preventing pneumonia and increasing the survival rate from pneumonia. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Pneumonia
What is being tested?: Pneumococcal vaccination (Pneumovax NP, 21800AMY10131000), Influenza vaccination (Flubik HA, 16100EZZ01207000) and Specific frequency of oral care
Type of treatment: Vaccines, Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 199 participants
Where: 1 siteJapan
Study dates: Nov 2009to Oct 2010
Phase: Interventional
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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

The residents or an agent who understand the purpose of this study and give informed consent.

Who cannot join

The residents contraindicated to vaccine

Trial locations and contacts

1 site in 1 country.

Japan1 site

Yubari Kibounomori
Yūbari, Hokkaido, 068-0402

Other trials in Japan

About this study

Official title: The Interventional Study in the Effects of Oral Care With Vaccines at Nursing Home; the Role of the Partnership With Physician, Dentist and Other Co-medical Stuff

Prospective study comparing the effects of interventions (combined oral care and pneumococcal plus influenza vaccinations) in preventing pneumonia and increasing the survival rate from pneumonia.

Read the detailed description

The elderly population can be expected to increase not only in developed countries, but also in developing countries. Pneumonia is one of the most common causes of death in the elderly.

The investigators conducted a prospective study comparing the effects of interventions (combined oral care and pneumococcal plus influenza vaccinations) in preventing pneumonia and increasing the survival rate from pneumonia in consecutive elderly patients at a nursing home in Yubari during one year from 2009, with the results in a non-intervention group.

Conditions: Pneumonia
Being tested: Pneumococcal vaccination (Pneumovax NP, 21800AMY10131000), Influenza vaccination (Flubik HA, 16100EZZ01207000), Specific frequency of oral care
Keywords: Oral care, Vaccine, Pneumonia, Elderly, Prevention, Primary care
Medical subject headings: Pneumonia

What participants receive

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

Pneumococcal vaccination (Pneumovax NP, 21800AMY10131000)Biological
Also called Pneumovax NP, Serial Number: 21800AMY10131000
Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day
Influenza vaccination (Flubik HA, 16100EZZ01207000)Biological
Also called Flubik HA, Serial Number: 16100EZZ01207000
Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day
Influenza vaccination (Flubik HA, 16100EZZ01207000)Biological
Also called Flubik HA, Serial Number: 16100EZZ01207000
Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day
Specific frequency of oral careOther
Also called Not applicable:Behaviour
1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room primary care physicians. At the same time, they taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material.

Study groups in NCT01403805
Study group	Role	What they receive
Oral care and vaccines	Experimental	Oral care and pneumococcal plus influenza vaccines Receives: Biological: Pneumococcal vaccination (Pneumovax NP, 21800AMY10131000); Biological: Influenza vaccination (Flubik HA, 16100EZZ01207000); Other: Specific frequency of oral care
Vaccine	Active comparator	Influenza vaccine only Receives: Biological: Influenza vaccination (Flubik HA, 16100EZZ01207000)

What is being measured

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

Number of Participants With Pneumonia
Number of Participants with Pneumonia sufferers
Measured: 1 year

Secondary outcomes (1)

Death From Pneumonia
Number of participants for the death from pneumonia
Measured: 1 year

Timeline

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

Nov 2009Oct 2010

First posted27 Jul 2011 (estimated)
Study startNov 2009
Primary completionOct 2010
Study completionOct 2010

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.
Other trials for PneumoniaStudies of the same condition, open and under way.
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 N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 199 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01403805
Sponsor's protocol ID: 803121
Status last verified: Apr 2012
First submitted: 25 Jul 2011
Last updated: 1 May 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection

All Pneumonia trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Interventional Study in the Effects of Oral Care With Vaccines at Nursing Home; the Role of the Partnership With Physician, Dentist and Other Co-medical Stuff
ClinicalTrials.gov ID: NCT01403805
Acronym / sponsor ID: 803121
Conditions: Pneumonia
Keywords: Oral care, Vaccine, Pneumonia, Elderly, Prevention, Primary care
Study type: Interventional
Recruitment status: Completed
Enrolment: 199 participants (actual)
Lead sponsor: Yubari KibounomoriUniversity, hospital or other
Collaborators: Health Research Foundation
Study start: Nov 2009
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 27 Jul 2011 (estimated)
Results: Posted 1 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Prospective study comparing the effects of interventions (combined oral care and pneumococcal plus influenza vaccinations) in preventing pneumonia and increasing the survival rate from pneumonia.

Detailed description

The elderly population can be expected to increase not only in developed countries, but also in developing countries. Pneumonia is one of the most common causes of death in the elderly.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Oral care and vaccines	Experimental	Biological: Pneumococcal vaccination (Pneumovax NP, 21800AMY10131000), Biological: Influenza vaccination (Flubik HA, 16100EZZ01207000), Other: Specific frequency of oral careOral care and pneumococcal plus influenza vaccines
Vaccine	Active comparator	Biological: Influenza vaccination (Flubik HA, 16100EZZ01207000)Influenza vaccine only

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

The residents or an agent who understand the purpose of this study and give informed consent.

Key exclusion criteria (1 listed)

The residents contraindicated to vaccine

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
Pneumococcal vaccination (Pneumovax NP, 21800AMY10131000)Also: Pneumovax NP, Serial Number: 21800AMY10131000Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day	Biological	Oral care and vaccines
Influenza vaccination (Flubik HA, 16100EZZ01207000)Also: Flubik HA, Serial Number: 16100EZZ01207000Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day	Biological	Oral care and vaccines
Influenza vaccination (Flubik HA, 16100EZZ01207000)Also: Flubik HA, Serial Number: 16100EZZ01207000Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day	Biological	Vaccine
Specific frequency of oral careAlso: Not applicable:Behaviour1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room primary care physicians. At the same time, they taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material.	Other	Oral care and vaccines

Primary outcome

Number of Participants With Pneumonia
Time frame: 1 year
Number of Participants with Pneumonia sufferers

1 secondary outcome

Death From Pneumonia
Time frame: 1 year

Results and safety

Results posted to the registry on 1 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Influenza Vaccine	94	94
Oral Care With Influenza and Pneumococcal Vaccines	105	98

Primary outcome: Number of Participants With Pneumonia

Time frame: 1 year. Number. Unit: participants

Measure	Influenza Vaccine n = 94	Oral Care With Influenza and Pneumococcal Vaccines n = 105
Value	21	2

Influenza Vaccine vs Oral Care With Influenza and Pneumococcal Vaccines: p <0.001, Fisher Exact

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Influenza Vaccine	8 of 94 (8.5%)	0 of 94 (0%)	Not reported
Oral Care With Influenza and Pneumococcal Vaccines	2 of 105 (1.9%)	0 of 105 (0%)	Not reported

Limitations and caveats (from the sponsor): small numbers of subjects analyzed

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pneumonia

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection

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.

Hirofumi Hashimoto, M.D.,Ph.D. study director

Yubari Health Care Research Center

Masahiro Hatta, D.D.S. study chair

Yubari Kibounomori

Takahiro Ichiki, M.D. study director

Mukawa town National Health Insurance Hobetsu clinic

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

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 1 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 1 May 2012. 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 Japan. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2012). 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?

Number of Participants With Pneumonia (time frame: 1 year). 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 NCT01403805.

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 1 May 2012.