Actively Recruiting

Age: 0Years - 14Years
All Genders
Healthy Volunteers
NCT06815588

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

Led by Research Center Borstel · Updated on 2025-02-07

100

Participants Needed

1

Research Sites

80 weeks

Total Duration

On this page

Sponsors

R

Research Center Borstel

Lead Sponsor

L

LMU Klinikum

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0Years - 14Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • Refusal to sign informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Marius Nasta Institute of Pneumology

Bucharest, BUC, Romania, 050159

Actively Recruiting

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Research Team

A

Anca Vasiliu, MD, PhD

CONTACT

D

Dragos Baiceanu, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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