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
• Status: Recruiting
• 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
• 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
• 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)

Related Conditions & MeSH terms

• Emergencies
• Empyema
• Pleural Effusion
• Pneumonia

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