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RecruitingNCT05274607Updated Oct 27, 2026

Pneumonia and Pleuropneumonia in Hospitalized Children

An observational study in Pneumonia and Pleural Effusion, sponsored by Association Clinique Thérapeutique Infantile du val de Marne. Recruiting at 1 site in France. Open to participants aged 1 Month to 15 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Association Clinique Thérapeutique Infantile du val de Marne · Observational

From the registry’s dates

  • Started Jun 2009; still recruiting 17 years 5 months later.
Updated Oct 27, 2026Primary completion movedStudy completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20,000
Ages
1 Month to 15 Years
Sex
All
01

Study summary

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

Read the detailed description

The pneumonia observatory began in June 2009 and has included more than 15,000 children with pneumonia or pleuropneumonia 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 or pleuropneumonia, 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.
02

Conditions studied

  • Pneumonia
  • Pleural Effusion

Keywords

  • children
  • pneumococcal conjugate vaccine
03

In context

Pneumonia

1,564 studies on the registry are indexed under Pneumonia; 265 are open to participants now.

This study's planned enrollment of 20,000 is above the median of 252 across 535 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Association Clinique Thérapeutique Infantile du val de Marne is the lead sponsor of 15 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 15 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Hospitalized children presenting with pneumonia or pleural effusion

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Refusal of participation by the patient, his or her relative or legal representative (depending on the situation)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20,000 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 20 years

Secondary outcomes

  1. Impact of pneumococcal conjugate vaccines

    Measuring the impact of PCV vaccines on pneumonia and pleural effusion

    Time frame: 20 years

  2. Treatments

    Describe the therapeutics in place

    Time frame: 20 years

07

Study locations

1 of 1 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Primary completion
Jun 1, 2025→Dec 1, 2029
Oct 27, 2026
Study completion
Jun 1, 2025→Dec 1, 2029
Oct 27, 2026
Primary outcomes
1 time frame changed, 1 description edited
What changed in the outcomes
  • Time frameEpidemiology of hospitalized pediatric pneumonia and pneumonia with pleural effusion15 years → 20 years
  • DescriptionEpidemiology of hospitalized pediatric pneumonia and pneumonia with pleural effusion: how it is measured was reworded
Oct 27, 2026
Secondary outcomes
2 time frame changed
What changed in the outcomes
  • Time frameImpact of pneumococcal conjugate vaccines15 years → 20 years
  • Time frameTreatments15 years → 20 years
Oct 27, 2026
Title
Pneumonia and EmpyemaPleuropneumonia in Emergency Departments inHospitalized Children
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Primary completion Jun 1, 2025→Dec 1, 2029
    Study completion Jun 1, 2025→Dec 1, 2029
    Primary outcomes 1 time frame changed, 1 description edited
    What changed in the outcomes
    • Time frameEpidemiology of hospitalized pediatric pneumonia and pneumonia with pleural effusion15 years → 20 years
    • DescriptionEpidemiology of hospitalized pediatric pneumonia and pneumonia with pleural effusion: how it is measured was reworded
    Secondary outcomes 2 time frame changed
    What changed in the outcomes
    • Time frameImpact of pneumococcal conjugate vaccines15 years → 20 years
    • Time frameTreatments15 years → 20 years
    Title Pneumonia and EmpyemaPleuropneumonia in Emergency Departments inHospitalized Children
    + 5 other changes: index terms, verification date, description, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT05274607
Lead sponsor
Association Clinique Thérapeutique Infantile du val de Marne
Collaborators
Pfizer
Responsible party
Sponsor
First posted
Mar 10, 2022
Start date
Jun 1, 2009
Primary completion
Dec 1, 2029 (estimated)
Completion
Dec 1, 2029 (estimated)
Last update
Oct 27, 2026

Study contacts

Corinne Levy, MD
Contact
corinne.levy@activ-france.fr
Robert Cohen, MD
study director · Groupe de Pathologies Infectieuses Pédiatriques (GPIP)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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