Evaluating the impact of pneumococcal vaccination on invasive infections in children
Population-based Nationwide Study on Invasive Pneumococcal Infections Among Children (0-18 Years) in France
Association Clinique Thérapeutique Infantile du val de Marne · NCT04664556
This study is trying to see how well the pneumococcal vaccines are working to protect children from serious infections caused by pneumococcus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 1 Day to 18 Years |
| Sex | All |
| Sponsor | Association Clinique Thérapeutique Infantile du val de Marne (other) |
| Locations | 1 site (Créteil) |
| Trial ID | NCT04664556 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effects of the 7 and 13 valent pneumococcal conjugate vaccines implemented in France on invasive pneumococcal disease (IPD) in children. It will involve the collection and analysis of clinical data related to IPD cases, including serotyping of the pneumococcus, underlying health conditions, and vaccination status of the affected individuals. The study will utilize isolates from various sterile body sites to understand the epidemiology of IPD post-vaccination.
Who should consider this trial
Good fit: Ideal candidates for this study are children who have been diagnosed with invasive pneumococcal disease and have a confirmed isolate of Streptococcus pneumoniae.
Not a fit: Patients who do not have a confirmed pneumococcal infection or whose strains are not transmitted to the National Reference Center for Pneumococci may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of pneumococcal vaccines in reducing severe infections in children.
How similar studies have performed: Other studies have shown success in evaluating the impact of pneumococcal vaccines on disease incidence, making this approach both relevant and supported by prior findings.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Créteil
- ACTIV — Créteil, France (RECRUITING)
Study contacts
- Principal investigator: Cohen Robert — Association Clinique Thérapeutique Infantile du val de Marne
- Study coordinator: Levy Corinne
- Email: corinne.levy@activ-france.fr
- Phone: 1 48 85 04 04
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pneumococcal Infections, Pneumococcal Conjugate Vaccine, Antibiotic Treatment, Mortality