Disease Burden of Pneumonia, Meningitis and Bacteremia Among Children in Japan: Pneumonet Japan

March 26, 2012 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

28511

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hokkaido
      • Kushiro, Hokkaido, Japan, 085-0032
    • Okinawa
      • Naha City, Okinawa, Japan, 900-0034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants and children less than 5 years of age living in Okinawa and Eastern Hokkaido.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2-3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

September 19, 2008

First Submitted That Met QC Criteria

September 22, 2008

First Posted (Estimate)

September 23, 2008

Study Record Updates

Last Update Posted (Estimate)

March 27, 2012

Last Update Submitted That Met QC Criteria

March 26, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0887X1-4424

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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