Invasive Pneumococcal Disease Study

Recruiting

• Conditions: Antibiotic Treatment; Pneumococcal Infections; Pneumococcal Conjugate Vaccine; Mortality
• Interventions: Other: observational study

• Registration Number: NCT04664556
• Lead Sponsor: Association Clinique Thérapeutique Infantile du val de Marne

Brief Summary

After 7 then 13 valent pneumococcal conjugate vaccine 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

Not available

Study Timeline

• Study Start: 2010-12-13
• Study First Submitted: 2020-12-07
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-11
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-30
• Primary Completion: 2030-01-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1369

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 PCR.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort of invasive pneumococcal disease in children	observational study	-

Primary Outcome Measures

Name	Time	Method
Severity of invasive pneumococcal disease	before hospital discharge	Number of severe cases according to age and pneumococcal serotypes distribution

Secondary Outcome Measures

Name	Time	Method
Impact of vaccines	before hospital discharge	Number of invasive pneumococcal disease according to vaccine serotypes

Trial Locations

Locations (1)

ACTIV; 🇫🇷 Créteil, France