Clinical Trial

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

Study acronym: RoGer Pedi
Recruiting
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Record status
This record was last updated February 7, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT06815588
Lead Sponsor Research Center Borstel
Collaborators: LMU Klinikum
Conditions Tuberculosis
Enrollment 100 participants
Start Date 2024-09-15
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-03-30 (estimated)
Updated on ClinicalTrials.gov 2025-02-07