Improving diagnosis and treatment monitoring for children with tuberculosis
Improving the Outcomes of Children With Tuberculosis Through Innovative Diagnostics and Treatment Monitoring
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 0 Years to 14 Years |
| Sex | All |
| Sponsor | Research Center Borstel Academic / other |
| Locations | 1 site (Bucharest, BUC) |
| Trial ID | NCT06815588 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 15 years who are being evaluated for respiratory tuberculosis.
Not a fit: Patients who refuse to sign the informed consent form will not benefit from this study.
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 performed: Other studies have explored innovative diagnostic approaches for tuberculosis in children, showing promise in improving diagnosis, but this specific methodology is relatively novel.
Eligibility criteria
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 this trial is running
Bucharest, BUC
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.