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Clinical Trials/NCT04664556
NCT04664556RecruitingNot Applicable

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

Association Clinique Thérapeutique Infantile du val de Marne2 sites in 1 country2,500 target enrollmentStarted: December 13, 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
2,500
Locations
2
Primary Endpoint
Severity of invasive pneumococcal disease
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

After 7 then 13 valent pneumococcal conjugate vaccine (PCV) 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.

Detailed Description

For children under 18, hospitalized for IPD, the following data will be analyzed: risk factors, vaccination status, severity signs , treatment during hospitalization, biological analysis, the clinical location of the disease.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
1 Day to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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 polymerase chain reaction (PCR).

Exclusion Criteria

  • •Pneumococcal strain not transmetted to National Reference Center for Pneumococci or to Regional Pneumococci Observatory

Outcomes

Primary Outcomes

Severity of invasive pneumococcal disease

Time Frame: before hospital discharge

Number of severe cases according to age and pneumococcal serotypes distribution

Secondary Outcomes

  • Impact of vaccines(before hospital discharge)

Investigators

Sponsor
Association Clinique Thérapeutique Infantile du val de Marne
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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