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NCT06815588Recruiting

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

Source: ClinicalTrials.gov · Last updated 7 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
17 Dec 2024
Start date
15 Sept 2024
Primary completion date
31 Dec 2025
Lead sponsor
Research Center Borstel
Diseases
Tuberculosis
NCT number
NCT06815588

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 15 Sept 2024 to the primary completion date, 31 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • \- Refusal to sign informed consent

Who the study is looking for

  • 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.

Age in the registry: 0 years to 14 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Marius Nasta Institute of Pneumology
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.