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NCT Number: NCT04664556

National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns

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.

Recruiting

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Key information

Conditions

Pneumococcal Infections Antibiotic Treatment Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mortality Pneumococcal Conjugate Vaccine Streptococcal Infections

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Severity of invasive pneumococcal disease

    Time frame: before hospital discharge

    Number of severe cases according to age and pneumococcal serotypes distribution

Secondary outcomes

  1. Impact of vaccines

    Time frame: before hospital discharge

    Number of invasive pneumococcal disease according to vaccine serotypes

Study contacts

Contact information is provided by the study sponsor or research team.

Bechet Stephane

CONTACT

[email protected]

1 48 85 96 68 ext. +33

Levy Corinne

CONTACT

[email protected]

1 48 85 04 04 ext. +33

Sponsors and collaborators

Lead sponsor

Association Clinique Thérapeutique Infantile du val de Marne

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Acronym: IPD

Important dates

Study start
2010
Primary completion
2030
Study completion
2030
First posted
Dec 11, 2020
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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