NCT05274607

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
12.8 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

February 8, 2024

Status Verified

January 1, 2024

Enrollment Period

16 years

First QC Date

March 2, 2022

Last Update Submit

February 7, 2024

Conditions

PneumoniaPleural Effusion

Keywords

childrenpneumococcal conjugate vaccine

Outcome Measures

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.

    15 years

Secondary Outcomes (2)

  • Impact of pneumococcal conjugate vaccines

    15 years

  • Treatments

    15 years

Eligibility Criteria

Age1 Month - 15 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Hospitalized children presenting with pneumonia or pleural effusion

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ACTIV

Créteil, 94000, France

RECRUITING

MeSH Terms

Conditions

PneumoniaPleural Effusion

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesPleural Diseases

Study Officials

  • Robert Cohen, MD

    Groupe de Pathologies Infectieuses Pédiatriques (GPIP)

    STUDY DIRECTOR

Central Study Contacts

Corinne Levy, MD

CONTACT

corinne.levy@activ-france.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2022

First Posted

March 10, 2022

Study Start

June 1, 2009

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

February 8, 2024

Record last verified: 2024-01

Locations

FR(1)