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.
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.
None
All potential participants presenting with the inclusion criteria, will be asked to participate in the study upon their parent/guardian consent and their assent, if applicable. Information will be provided about the study and the risks and benefits of participating. Both the child and the parent/guardian are then asked to consent (or assent) to the participation in the study and any questions they might have are answered. The enrollment is complete after the signature of the informed consent form (ICF). If the child or their parent/guardian does not wish to participate in the study, they will receive the standard of care.
Cohort
Prospective
Not listed
Stool diagnostic accuracy
Evaluate the diagnostic accuracy of stool and perform targeted next generation sequencing from stool for drug sensitivity testing.
Biomarkers for treatment monitoring
Assess the utility of a transcriptomic signature composed of a 22-gene RNA model (TB22 - PMID: 33574078) for treatment monitoring and treatment shortening in children treated for respiratory tuberculosis.
Masks diagnostic accuracy
Identify the diagnostic accuracy of mask strip samples against a composite reference standard for the diagnosis of respiratory tuberculosis in children.
Urinary LAM diagnostic accuracy
Determine the diagnostic accuracy of a novel urinary LAM assay against a composite reference standard for the diagnosis of respiratory tuberculosis in children.
Post-TB lung disease assessment
Measure the forced vital capacity as a marker of lung function in children diagnosed with respiratory tuberculosis using spirometry.
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Research Center Borstel
Lead sponsor
LMU Klinikum
Collaborator
