Disease Burden Of Pneumonia, Meningitis and Bacteremia Among Children in Japan:Pneumonet Japan - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00757575

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

MedlinePlus related topics: Meningitis Pneumonia

U.S. FDA Resources

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

Further study details as provided by Wyeth:

Primary Outcome Measures:

Describe the distribution of causal pathogen of meningitis and bacteremia [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Estimate the hospital admission rate of pneumonia patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Estimate the incidence rate of IPD [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Describe the serotype distribution of S [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CFRof patients admitted with IPD and/or pneumonia [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]
Antibiotic resistance rate of S. pneumoniae [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]
Risk factor distribution [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]
Average duration of the hospitalization of patients with IPD, meningitis, and/or pneumonia [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	10000
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
1

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

Inclusion 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.

Exclusion Criteria:

Contacts and Locations

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

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

Japan
	Recruiting
Okinawa, Japan, 900-0034
Japan, Hokkaido
	Recruiting
Kushiro, Hokkaido, Japan, 085-0032

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, Dr. Riko Nakamura

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0887X1-4424
Study First Received:	September 19, 2008
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00757575 History of Changes
Health Authority:	Japan: Hokkaido University School of Medicine Institutional Review Board

Keywords provided by Wyeth:

PNEUMONET JAPAN STUDY

Study placed in the following topic categories:

Bacteremia
Pneumonia
Meningitis

ClinicalTrials.gov processed this record on May 07, 2009