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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00757575
First received: September 19, 2008
Last updated: March 26, 2012
Last verified: March 2012
  Purpose

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.


Condition
Pneumococcal Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiological Surveillance Network Study To Assess the Disease of Pneumonia in Infants and Children in Japan

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 28511
Study Start Date: February 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   up to 60 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757575

Locations
Japan
Kushiro, Hokkaido, Japan, 085-0032
Naha City, Okinawa, Japan, 900-0034
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00757575     History of Changes
Other Study ID Numbers: 0887X1-4424
Study First Received: September 19, 2008
Last Updated: March 26, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Pfizer:
PNEUMONET JAPAN STUDY

ClinicalTrials.gov processed this record on October 19, 2014