PneumoniaNCT05274607
Pneumonia and Pleuropneumonia in Hospitalized Children
An observational study of Pneumonia and Pleural Effusion, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 1 month to 15 years
- Conditions the study is for
- Pneumonia, Pleural Effusion
- How many people
- 20,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2009to 1 Dec 2029
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 15 years
- All sexes
- Child
Study population: Hospitalized children presenting with pneumonia or pleural effusion
Who may be able to join
- 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
Who cannot join
- Refusal of participation by the patient, his or her relative or legal representative (depending on the situation)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Corinne Levy, MD contact
France1 site, 1 recruiting
- Recruiting
ACTIV
Créteil, 94000
Corinne Levy, MD, 0033148850404, corinne.levy@activ-france.fr
Stéphane Béchet, MSc, 0033148850404, stephane.bechet@activ-france.fr
About this study
Official title: French Epidemiological Pediatric Study for Pneumonia and Pleuropneumonia in Hospitalized Children Aged 1 Months to 15 Years.
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.
- Conditions
- Pneumonia, Pleural Effusion
- Keywords
- children, pneumococcal conjugate vaccine
- Medical subject headings
- Pneumonia, Pleural Effusion
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 years
Secondary outcomes (2)
Impact of pneumococcal conjugate vaccines
Measuring the impact of PCV vaccines on pneumonia and pleural effusion
Measured: 20 years
Treatments
Describe the therapeutics in place
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start1 Jun 2009
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de Marne
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Robert Cohen, MD, Study director, Groupe de Pathologies Infectieuses Pédiatriques (GPIP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274607
- Sponsor's protocol ID
- ACT0209
- Status last verified
- Apr 2026
- First submitted
- 2 Mar 2022
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Epidemiological Pediatric Study for Pneumonia and Pleuropneumonia in Hospitalized Children Aged 1 Months to 15 Years.
- ClinicalTrials.gov ID
- NCT05274607
- Acronym / sponsor ID
- ACT0209
- Conditions
- Pneumonia, Pleural Effusion
- Keywords
- children, pneumococcal conjugate vaccine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de MarneUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 1 Jun 2009 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 1 month to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- Hospitalized children presenting with pneumonia or pleural effusion
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal of participation by the patient, his or her relative or legal representative (depending on the situation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epidemiology of hospitalized pediatric pneumonia and pneumonia with pleural effusion
Time frame: 20 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.
2 secondary outcomes
Impact of pneumococcal conjugate vaccines
Time frame: 20 years
Treatments
Time frame: 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Corinne Levy, MD contact
Robert Cohen, MD study director
Groupe de Pathologies Infectieuses Pédiatriques (GPIP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Pleural Effusion, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corinne Levy, MD (corinne.levy@activ-france.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiology of hospitalized pediatric pneumonia and pneumonia with pleural effusion (time frame: 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.