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NCT00757575 Clinical Trial

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

Pneumococcal Disease Clinical Trial

Official title:
Epidemiological Surveillance Network Study To Assess the Disease of Pneumonia in Infants and Children in Japan

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00757575
Other study ID # 0887X1-4424
Secondary ID
Status Completed
Phase N/A
First received September 19, 2008
Last updated March 26, 2012
Start date February 2008
Est. completion date October 2010

Study information
Verified date March 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Observational

Clinical 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 about pneumococcal disease burden is available in Japan.

Recruitment information / eligibility
Status Completed
Enrollment 28511
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group N/A to 60 Months
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 2 years No
Secondary 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. 2-3 years No
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