Improving diagnosis and treatment monitoring for children with tuberculosis
Official title: Improving the Outcomes of Children With Tuberculosis Through Innovative Diagnostics and Treatment Monitoring
Run by Research Center Borstel · NCT06815588 · Data updated 2026-11-12
This study is testing new ways to diagnose and track treatment for tuberculosis in children by using different samples and checking their lung health and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Years to 14 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Research Center Borstel Academic / other |
| Locations | 1 site (Bucharest, BUC) |
| Status | Recruiting |
| Started | September 15, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | March 30, 2026 |
| Registry record updated | February 7, 2025 |
| Trial ID | NCT06815588 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children under 15 years who are being evaluated for respiratory tuberculosis.
✕Probably not a fit
Patients who refuse to sign the informed consent form will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on enhancing the diagnosis and treatment of respiratory tuberculosis in children by evaluating innovative diagnostic methods using alternative samples such as stool, urine, and masks. The study will also monitor treatment outcomes through next-generation sequencing to check for drug resistance and will assess lung capacity and quality of life through spirometry and questionnaires. By addressing the unique challenges of diagnosing TB in pediatric populations, the study aims to improve overall treatment outcomes for affected children.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and less invasive diagnostic methods for pediatric tuberculosis, ultimately improving treatment outcomes.
How similar studies have gone: Other studies have explored innovative diagnostic approaches for tuberculosis in children, showing promise in improving diagnosis, but this specific methodology is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria * 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. Exclusion criteria \- Refusal to sign informed consent
Where it's running
-
Marius Nasta Institute of Pneumology
Bucharest, Buc, Romania Recruiting
Study contacts
- Principal investigator: Christoph Lange, Professor — Research Center Borstel
- Study coordinator: Anca Vasiliu, MD, PhD
- Email: avasiliu@fz-borstel.de
- Phone: +33652727749
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Isoniazid inhalation in TB patients: a first-in-human look at local tolerability and body levels
This early study tests inhaled isoniazid to see how well it tolerates the lungs and how it behaves in the body in adults with tuberculosis.
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This study tests how the immune system changes in people with tuberculosis and related mycobacterial infections.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.