Invasive Pneumococcal Disease Study
Sponsor
Association Clinique Thérapeutique Infantile du val de Marne (Other)
Overall Status
Recruiting
CT.gov ID
NCT04664556
Collaborator
Pfizer (Industry)
1,205
2
240
602.5
2.5
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
1205 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Population-based Nationwide Study on Invasive Pneumococcal Infections Among Children (0-18 Years) in France
Actual Study Start Date
:
Jan 1, 2010
Anticipated Primary Completion Date
:
Jan 1, 2030
Anticipated Study Completion Date
:
Jan 1, 2030
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort of invasive pneumococcal disease in children
|
Other: observational study
observational study
|
Outcome Measures
Primary Outcome Measures
- Severity of invasive pneumococcal disease [before hospital discharge]
Number of severe cases according to age and pneumococcal serotypes distribution
Secondary Outcome Measures
- Impact of vaccines [before hospital discharge]
Number of invasive pneumococcal disease according to vaccine serotypes
Eligibility Criteria
Criteria
Ages Eligible for Study:
0 Days
to 18 Years
Sexes Eligible for Study:
All
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:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ACTIV | Creteil | France | 94000 | |
| 2 | ACTIV | Créteil | France | 94000 |
Sponsors and Collaborators
- Association Clinique Thérapeutique Infantile du val de Marne
- Pfizer
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Invasive Disease Potential of Pneumococcal Serotypes in Children After PCV13 Implementation
- Changes in Invasive Pneumococcal Disease Spectrum After 13-Valent Pneumococcal Conjugate Vaccine Implementation
Publications
None provided.Responsible Party:
Association Clinique Thérapeutique Infantile du val de Marne
ClinicalTrials.gov Identifier:
NCT04664556
Other Study ID Numbers:
- IPD
First Posted:
Dec 11, 2020
Last Update Posted:
Mar 22, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: