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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04664556
Acronym
IPD
Enrollment
2500
Registered
2020-12-11
Start date
2010-12-13
Completion date
2030-01-01
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Treatment, Mortality, Pneumococcal Conjugate Vaccine, Pneumococcal Infections

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.

Interventions

None listed

Sponsors

Association Clinique Thérapeutique Infantile du val de Marne
Lead SponsorOTHER
Pfizer
CollaboratorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 18 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Severity of invasive pneumococcal diseasebefore hospital dischargeNumber of severe cases according to age and pneumococcal serotypes distribution

Secondary

MeasureTime frameDescription
Impact of vaccinesbefore hospital dischargeNumber of invasive pneumococcal disease according to vaccine serotypes

Countries

France

Contacts

CONTACTLevy Corinne
corinne.levy@activ-france.fr1 48 85 04 04
CONTACTBechet Stephane
stephane.bechet@activ-france.fr1 48 85 96 68
STUDY_DIRECTORLevy Corinne

Association Clinique Thérapeutique Infantile du val de Marne

PRINCIPAL_INVESTIGATORCohen Robert

Association Clinique Thérapeutique Infantile du val de Marne

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026