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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorAssociation Clinique Thérapeutique Infantile du val de Marne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial population

Children with invasive pneumococcal disease for whom the pneumococcal strain is sent to the National reference Center for Pneumococci for serotyping

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Severity of invasive pneumococcal disease

Number of severe cases according to age and pneumococcal serotypes distribution

Time frame
before hospital discharge

Secondary outcomes

1

Impact of vaccines

Number of invasive pneumococcal disease according to vaccine serotypes

Time frame
before hospital discharge

Other outcomes

Sponsors and contacts

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