NCT00757575

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28,511

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2008

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

March 27, 2012

Status Verified

March 1, 2012

Enrollment Period

2.7 years

First QC Date

September 19, 2008

Last Update Submit

March 26, 2012

Conditions

Pneumococcal Disease

Keywords

PNEUMONET JAPAN STUDY

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Secondary Outcomes (1)

  • 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.

    2-3 years

Study Arms (1)

1

Eligibility Criteria

Age28 Days - 60 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants and children less than 5 years of age living in Okinawa and Eastern Hokkaido.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Kushiro, Hokkaido, 085-0032, Japan

Location

Unknown Facility

Naha, Okinawa, 900-0034, Japan

Location

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Pfizer CT.gov Call Center

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2008

First Posted

September 23, 2008

Study Start

February 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

March 27, 2012

Record last verified: 2012-03

Locations

JP(2)