Disease Burden of Pneumonia, Meningitis and Bacteremia Among Children in Japan: Pneumonet Japan
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00757575
First received: September 19, 2008
Last updated: March 26, 2012
Last verified: March 2012
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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
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 |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 23, 2013