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NCT05274607 Clinical Trial

Pneumonia and Empyema in Emergency Departments in Children

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05274607
Other study ID # ACT0209
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2009
Est. completion date June 1, 2025

Study information
Verified date January 2024
Source Association Clinique Thérapeutique Infantile du val de Marne
Contact Corinne Levy, MD
Email corinne.levy@activ-france.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20000
Est. completion date June 1, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers
Gender All
Age group 1 Month to 15 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France ACTIV Créteil

Sponsors (2)
Lead Sponsor Collaborator
Association Clinique Thérapeutique Infantile du val de Marne Pfizer

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Epidemiology of hospitalized pediatric pneumonia and pneumonia with pleural effusion - 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. 15 years
Secondary Impact of pneumococcal conjugate vaccines Measuring the impact of PCV vaccines on pneumonia and pleural effusion 15 years
Secondary Treatments Describe the therapeutics in place 15 years
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