Pneumococcal DiseaseNCT00757575
Disease Burden of Pneumonia, Meningitis and Bacteremia Among Children in Japan: Pneumonet Japan
An observational study of Pneumococcal Disease, run by Pfizer at 2 sites in Japan.
Trial summary
Streptococcus pneumoniae is a major cause of pneumonia, among infants and children in Japan and worldwideThis study plans to investigate the rate of invasive pneumococcal disease "IPD " and the rate of hospitalizations due to pneumonia in Okinawa and the Eastern half of Hokkaido Currently, only a limited information… Read more about this study
- Who is it for?
- Ages 28 days to 60 months
- Conditions the study is for
- Pneumococcal Disease
- How many people
- 28,511 participants
- Where
- 2 sitesJapan
- Study dates
- Feb 2008to Oct 2010
- Phase
- Observational
- 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 28 days to 60 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants and children less than 5 years of age living in Okinawa and Eastern Hokkaido.
Eligibility Criteria
- Children residing in the surveillance area(s) aged 28 days to <60 months with clinical suspicion of pneumonia, meningitis and bacteremia who were admitted to the hospital.
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Study site
Kushiro, Hokkaido, 085-0032
Study site
Naha, Okinawa, 900-0034
About this study
Official title: Epidemiological Surveillance Network Study To Assess the Disease of Pneumonia in Infants and Children in Japan
Streptococcus pneumoniae is a major cause of pneumonia, among infants and children in Japan and worldwideThis study plans to investigate the rate of invasive pneumococcal disease "IPD " and the rate of hospitalizations due to pneumonia in Okinawa and the Eastern half of Hokkaido Currently, only a limited information about pneumococcal disease burden is available in Japan.
- Conditions
- Pneumococcal Disease
- Keywords
- PNEUMONET JAPAN STUDY
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Describe the distribution of causal pathogen of meningitis and bacteremia 2.Estimate the hospital admission rate of pneumonia patients 3.Estimate the incidence rate of IPD 4.Describe the serotype distribution of S. pneumoniae
Measured: 2 years
Secondary outcomes (1)
1.CFRof patients admitted with IPD and/or pneumonia. 2.Antibiotic resistance rate of S. pneumoniae 3.Risk factor distribution 4.Average duration of the hospitalization of patients with IPD, meningitis, and/or pneumonia.
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startFeb 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28,511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757575
- Sponsor's protocol ID
- 0887X1-4424
- Status last verified
- Mar 2012
- First submitted
- 19 Sep 2008
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Surveillance Network Study To Assess the Disease of Pneumonia in Infants and Children in Japan
- ClinicalTrials.gov ID
- NCT00757575
- Acronym / sponsor ID
- 0887X1-4424
- Conditions
- Pneumococcal Disease
- Keywords
- PNEUMONET JAPAN STUDY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28,511 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 23 Sep 2008 (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.
Streptococcus pneumoniae is a major cause of pneumonia, among infants and children in Japan and worldwideThis study plans to investigate the rate of invasive pneumococcal disease "IPD " and the rate of hospitalizations due to pneumonia in Okinawa and the Eastern half of Hokkaido Currently, only a limited information about pneumococcal disease burden is available in Japan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 28 days to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants and children less than 5 years of age living in Okinawa and Eastern Hokkaido.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1.Describe the distribution of causal pathogen of meningitis and bacteremia 2.Estimate the hospital admission rate of pneumonia patients 3.Estimate the incidence rate of IPD 4.Describe the serotype distribution of S. pneumoniae
Time frame: 2 years
1 secondary outcome
1.CFRof patients admitted with IPD and/or pneumonia. 2.Antibiotic resistance rate of S. pneumoniae 3.Risk factor distribution 4.Average duration of the hospitalization of patients with IPD, meningitis, and/or pneumonia.
Time frame: 2-3 years
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 27 Mar 2012.
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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.
Pfizer CT.gov Call Center study director
Wyeth is now a wholly owned subsidiary of Pfizer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Disease, run by Pfizer at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 27 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
1.Describe the distribution of causal pathogen of meningitis and bacteremia 2.Estimate the hospital admission rate of pneumonia patients 3.Estimate the incidence rate of IPD 4.Describe the serotype distribution of S. pneumoniae (time frame: 2 years). 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 27 Mar 2012.