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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00757575
First Posted: September 23, 2008
Last Update Posted: March 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 60 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00757575     History of Changes
Other Study ID Numbers: 0887X1-4424
First Submitted: September 19, 2008
First Posted: September 23, 2008
Last Update Posted: March 27, 2012
Last Verified: March 2012

Keywords provided by Pfizer:
PNEUMONET JAPAN STUDY

Additional relevant MeSH terms:
Pneumonia
Pneumococcal Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections