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NCT04664556 Clinical Trial

Invasive Pneumococcal Disease Study

Mortality Clinical Trial

Official title:
Population-based Nationwide Study on Invasive Pneumococcal Infections Among Children (0-18 Years) in France

Clinical Trial Details — Status: Recruiting

Administrative data
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

Study information
Verified date October 2023
Source Association Clinique Thérapeutique Infantile du val de Marne
Contact Levy Corinne
Phone 1 48 85 04 04
Email corinne.levy@activ-france.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• observational study
observational study

Locations
Country Name City State
France ACTIV Creteil
France ACTIV Créteil

Sponsors (2)
Lead Sponsor Collaborator
Association Clinique Thérapeutique Infantile du val de Marne Pfizer

Country where clinical trial is conducted

France, 

Outcome
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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