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

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.
 
ClinicalTrials.gov Identifier: NCT00757575
Recruitment Status : Completed
First Posted : September 23, 2008
Last Update Posted : March 27, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date September 19, 2008
First Posted Date September 23, 2008
Last Update Posted Date March 27, 2012
Study Start Date February 2008
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 1, 2010)		 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 ]
Original Primary Outcome Measures
 (submitted: September 22, 2008)
  • Describe the distribution of causal pathogen of meningitis and bacteremia [ Time Frame: 2 years ]
  • Estimate the hospital admission rate of pneumonia patients [ Time Frame: 2 years ]
  • Estimate the incidence rate of IPD [ Time Frame: 2 years ]
  • Describe the serotype distribution of S [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures
 (submitted: April 1, 2010)		 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 ]
Original Secondary Outcome Measures
 (submitted: September 22, 2008)
  • CFRof patients admitted with IPD and/or pneumonia [ Time Frame: 2 years ]
  • Antibiotic resistance rate of S. pneumoniae [ Time Frame: 2 years ]
  • Risk factor distribution [ Time Frame: 2 years ]
  • Average duration of the hospitalization of patients with IPD, meningitis, and/or pneumonia [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Disease Burden of Pneumonia, Meningitis and Bacteremia Among Children in Japan: Pneumonet Japan
Official Title 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
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.
Condition Pneumococcal Disease
Intervention Not Provided
Study Groups/Cohorts 1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 26, 2012)		 28511
Original Estimated Enrollment
 (submitted: September 22, 2008)		 10000
Actual Study Completion Date October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 60 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT00757575
Other Study ID Numbers 0887X1-4424
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Pfizer
Verification Date March 2012