Pneumonia and Empyema in Emergency Departments in Children

NCT ID: NCT05274607

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-01

Study Completion Date

2025-06-01

Brief Summary

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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

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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.

Conditions

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Pneumonia Pleural Effusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

1 Month

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Association Clinique Thérapeutique Infantile du val de Marne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Cohen, MD

Role: STUDY_DIRECTOR

Groupe de Pathologies Infectieuses Pédiatriques (GPIP)

Locations

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ACTIV

Créteil, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Corinne Levy, MD

Role: CONTACT

Facility Contacts

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Corinne Levy, MD

Role: primary

0033148850404

Stéphane Béchet, MSc

Role: backup

0033148850404

Other Identifiers

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ACT0209

Identifier Type: -

Identifier Source: org_study_id

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