Mortality Clinical Trial
Official title:
Population-based Nationwide Study on Invasive Pneumococcal Infections Among Children (0-18 Years) in France
NCT number | NCT04664556 |
Other study ID # | IPD |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 13, 2010 |
Est. completion date | January 1, 2030 |
After 7 then 13 valent pneumococcal conjugate vaccine implementation in France in children, we will evaluate the impact of this vaccination on invasive pneumococcal disease (IPD). We will describe the clinical characteristics of IPD, pneumococcus serotyping, underlying conditions and vaccination status.
Status | Recruiting |
Enrollment | 1369 |
Est. completion date | January 1, 2030 |
Est. primary completion date | January 1, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 18 Years |
Eligibility | Inclusion Criteria: - Isolate of Streptococcus pneumoniae from at least one blood culture, or pleural fluid, or joint fluid, or cerebrospinal fluid or other normally sterile body site, or if there is a positive blood PCR. Exclusion Criteria: - Pneumococcal strain not transmetted to National Reference Center for Pneumococci or to Regional Pneumococci Observatory |
Country | Name | City | State |
---|---|---|---|
France | ACTIV | Creteil | |
France | ACTIV | Créteil |
Lead Sponsor | Collaborator |
---|---|
Association Clinique Thérapeutique Infantile du val de Marne | Pfizer |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Severity of invasive pneumococcal disease | Number of severe cases according to age and pneumococcal serotypes distribution | before hospital discharge | |
Secondary | Impact of vaccines | Number of invasive pneumococcal disease according to vaccine serotypes | before hospital discharge |
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