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
| Tracking Information | |||||
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| First Received Date ICMJE | September 19, 2008 | ||||
| Last Updated Date | March 26, 2012 | ||||
| Start Date ICMJE | February 2008 | ||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00757575 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Disease Burden of Pneumonia, Meningitis and Bacteremia Among Children in Japan: Pneumonet Japan | ||||
| Official Title ICMJE | Epidemiological Surveillance Network Study To Assess the Disease of Pneumonia in Infants and Children in Japan | ||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Infants and children less than 5 years of age living in Okinawa and Eastern Hokkaido. |
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| Condition ICMJE | Pneumococcal Disease | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 1 | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 28511 | ||||
| Completion Date | October 2010 | ||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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. |
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| Gender | Both | ||||
| Ages | up to 60 Months | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Japan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00757575 | ||||
| Other Study ID Numbers ICMJE | 0887X1-4424 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Pfizer | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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