Improving the Outcomes of Children With Tuberculosis Through Innovative Diagnostics and Treatment Monitoring

Recruiting now

Conditions studied: Tuberculosis

In brief

This study aims at identifying and evaluating novel diagnostic methods for children evaluated for respiratory tuberculosis. The investigators will use alternative samples like stool, urine, and masks to diagnose children with respiratory tuberculosis. Once diagnosed, the investigators will use target next generation sequencing to determine if the bacillus is resistant to any of the drugs used for treatment. Additionally, children initiated under TB treatment will be followed-up during treatment to measure blood biomarkers for outcome prediction. Finally, spirometry will be performed longitudinally until 3 months after the end of treatment to assess the lung capacity of children treated for respiratory TB. All children initiated on TB treatment will fill in a quality of life questionnaire.

Key facts

Study ID

NCT06815588

Run by

Research Center Borstel

People needed

100

Starts

2024-09-15

Expected to finish

2026-03-30

Last updated by the study team

2025-02-07

Who can join

Age: any, up to 14. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Children under 15 years evaluated for respiratory TB.
• Signature of the informed consent form by the parent/guardian and assent form by the child if applicable.

You may not qualify if…

• Refusal to sign informed consent

Where it is running

• Marius Nasta Institute of Pneumology — Bucharest, BUC, Romania (enrolling)

Full record on ClinicalTrials.gov

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