Pneumonia and Empyema in Emergency Departments in Children

Recruiting

• Conditions: Pneumonia; Pleural Effusion

• Registration Number: NCT05274607
• Lead Sponsor: Association Clinique Thérapeutique Infantile du val de Marne

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.

Study Timeline

• Study Start: 2009-06-01
• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-02
• Study First Posted: 2022-03-10
• Status Verified: 2024-01
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epidemiology of hospitalized pediatric pneumonia and pneumonia with pleural effusion	15 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 Outcome Measures

Name	Time	Method
Impact of pneumococcal conjugate vaccines	15 years	Measuring the impact of PCV vaccines on pneumonia and pleural effusion
Treatments	15 years	Describe the therapeutics in place

Trial Locations

Locations (1)

ACTIV; 🇫🇷 Créteil, France