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Pneumonia and Empyema in Emergency Departments in Children

French Epidemiological Pediatric Study on Pneumonia and Empyema in Emergency Departments in Children 1 Month to 15 Years

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05274607
Enrollment
20000
Registered
2022-03-10
Start date
2009-06-01
Completion date
2025-06-01
Last updated
2024-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleural Effusion, Pneumonia

Keywords

children, pneumococcal conjugate vaccine

Brief summary

Describe the epidemiology of hospitalized pediatric pneumonia and pneumonia with pleural effusion: frequency, clinical and biological characteristics, responsible bacteria and pneumococcus place, antibiotic resistance, treatment, vaccine status.

Detailed description

The pneumonia observatory began in June 2009 and has included more than 15,000 children with pneumonia or pneumonia with pleural effusion (hospitalized or not) until May 2019. This study led to the publication of many articles in international peer-reviewed journals. Since June 2019, the scientific committee of the study met at the ESPID congress has decided to include only hospitalized patients. This amendment is justified for three reasons: * Change in criteria for diagnosing pneumonia with increasing use of chest ultrasound * Logistical aspects and workload of investigating centers too important * Long-term impact of pneumococcal vaccine 13-valent especially marked for the most severe cases In this context, the purpose of this amended study is to enroll only the most severe cases of pneumonia, i.e. requiring hospitalization, in ICU or not. Since this study began in 2009, we have already enrolled hospitalized cases, we will have a baseline prior to the introduction of third-generation PCVs (pneumococcal conjugate vaccines) and we will be able to continue monitoring with data since 2009.

Interventions

None listed

Sponsors

Pfizer
CollaboratorINDUSTRY
Association Clinique Thérapeutique Infantile du val de Marne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 15 Years

Inclusion criteria

* ages between 1 month and 15 years * presence of parenchymatous condensation and/or pleural effusion on chest x-rays and/or ultrasounds and/or CT scans * fever ≥38.5 °C if age ≥3 months since the onset of symptoms or ≥38 °C if the child is less than 3 months old. * Hospitalization

Exclusion criteria

* Refusal of participation by the patient, his or her relative or legal representative (depending on the situation)

Design outcomes

Primary

MeasureTime frameDescription
Epidemiology of hospitalized pediatric pneumonia and pneumonia with pleural effusion15 years\- Describe the epidemiology of hospitalized pediatric pneumonia and pneumonia with pleural effusion: frequency, clinical and biological characteristics, responsible bacteria and pneumococcus place, antibiotic resistance, treatment, vaccine status.

Secondary

MeasureTime frameDescription
Impact of pneumococcal conjugate vaccines15 yearsMeasuring the impact of PCV vaccines on pneumonia and pleural effusion
Treatments15 yearsDescribe the therapeutics in place

Countries

France

Contacts

Primary ContactCorinne Levy, MD
corinne.levy@activ-france.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026