NCT06110533

Brief Summary

Pulmonary tuberculosis is the most common form of tuberculosis in children; According to the WHO, tuberculosis pulmonary tuberculosis in children represents approximately 80% of all cases of tuberculosis in children. In 2020, there were approximately 1.0 million new cases of pulmonary tuberculosis among children worldwide. In France, childhood tuberculosis remains a rare disease; the most recent data show a rate of 3.3 cases per 100,000 inhabitants among children under 15 years old in 2019. Pulmonary tuberculosis in children can lead to complications such as bronchiectasis and pneumothorax. Children living in homes where an adult has a active tuberculosis, or children with diseases chronic, malnourished or suffering from HIV are more likely to contract tuberculosis. The aim of this research is to determine the incidence, identify the risk factors as well as the clinical forms of pulmonary tuberculosis in children hospitalized at Strasbourg University Hospitals between 2012 and 2022.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

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

April 4, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2024

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

12 months

First QC Date

October 25, 2023

Last Update Submit

October 25, 2023

Conditions

Keywords

Pulmonary tuberculosisTuberculosis in childrenChildhood tuberculosisMycobacterium tuberculosis

Outcome Measures

Primary Outcomes (1)

  • Incidence and risk factors for pulmonary tuberculosis in children hospitalized at Strasbourg University Hospital between 2012 and 2022

    1 month after hospitalization for pulmonary tuberculosis

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Child (1 to 17 years old) hospitalized for pulmonary tuberculosis at Strasbourg University Hospital between January 1, 2012 and December 31, 2022.

You may qualify if:

  • Child (1 to 17 years old)
  • Child hospitalized for pulmonary tuberculosis at Strasbourg University Hospital between January 1, 2012 and December 31, 2022.
  • Child and/or his/her parental authority who have not expressed their opposition to the reuse of data for scientific research purposes.

You may not qualify if:

  • \- Subject and/or their parental authority having expressed their opposition to the re-use of the child's data for scientific research purposes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Ressources et de Compétences de la Mucoviscidose (CRCM) - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2023

First Posted

October 31, 2023

Study Start

April 4, 2023

Primary Completion

April 1, 2024

Study Completion

April 14, 2024

Last Updated

October 31, 2023

Record last verified: 2023-10

Locations