Pneumonia and Empyema in Emergency Departments in Children

Sponsor

Association Clinique Thérapeutique Infantile du val de Marne (Other)

Overall Status

Recruiting

CT.gov ID

NCT05274607

Collaborator

(none)

20,000

Enrollment

Location

180

Anticipated Duration (Months)

111.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia Pleural Effusion

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 and we will be able to continue monitoring with data since 2009.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

20000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2009

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Outcome Measures

Primary Outcome Measures

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

Impact of pneumococcal conjugate vaccines [15 years]
Measuring the impact of PCV vaccines on pneumonia and pleral effusion
Treatments [15 years]
Describe the therapeutics in place

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 15 Years

Sexes Eligible for Study:

All

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