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Invasive Pneumococcal Disease Study

NCT ID: NCT04664556

Last Updated: 2023-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1369 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-13

Study Completion Date

2030-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Pneumococcal Infections Pneumococcal Conjugate Vaccine Antibiotic Treatment Mortality

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort of invasive pneumococcal disease in children

observational study

Intervention Type OTHER

observational study

Interventions

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observational study

observational study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Association Clinique Thérapeutique Infantile du val de Marne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Levy Corinne

Role: STUDY_DIRECTOR

Association Clinique Thérapeutique Infantile du val de Marne

Cohen Robert

Role: PRINCIPAL_INVESTIGATOR

Association Clinique Thérapeutique Infantile du val de Marne

Locations

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ACTIV

Créteil, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Levy Corinne

Role: CONTACT

[email protected]
1 48 85 04 04 ext. +33

Bechet Stephane

Role: CONTACT

[email protected]
1 48 85 96 68 ext. +33

Facility Contacts

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Corinne Levy, MD

Role: primary

[email protected]
0033148850404

Stéphane Béchet, MSc

Role: backup

[email protected]
0033148850404

Other Identifiers

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IPD

Identifier Type: -

Identifier Source: org_study_id

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