National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pneumococcal Infections, Pneumococcal Conjugate Vaccine, Antibiotic Treatment, Mortality. Basic parameters: 1 Day — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Population-based Nationwide Study on Invasive Pneumococcal Infections Among Children (0-18 Years) in France
Overview
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.
Primary outcome measures
- Severity of invasive pneumococcal disease [Time frame: before hospital discharge]
Secondary outcome measures (1)
- Impact of vaccines [Time frame: before hospital discharge]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- ACTIV — Créteil
Publications
- Levy C, Estivaux A, Varon E, Bechet S, Ouldali N, Hau I, Cohen R. Pediatric Invasive Pneumococcal Disease Spectrum Before Third-Generation Pneumococcal Conjugate Vaccine Implementation. J Pediatric Infect Dis Soc. 2025 Aug 7;14(7):piaf056. doi: 10.1093/jpids/piaf056. PMID 40492721
Identifiers
NCT: NCT04664556 · IPD