NCT06239337Completed
Evaluation of Xpert MTB/RIF Ultra in Stools and Urine to Improve Tuberculosis Diagnosis in Children
Source: ClinicalTrials.gov · Last updated 2 Feb 2024
Brief summary (registry, in English)
Tuberculosis (TB) diagnosis in children is challenging in low and middle-income countries where access to TB culture and X-ray is limited. More than half cases of childhood TB remain undiagnosed every year. A delay in TB diagnosis can lead to an increase in preventable morbidity and mortality. This study aims to provide evidence on the diagnostic accuracy of Xpert MTB/RIF Ultra in stools and urine for TB diagnosis in children.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 563 (actual)
- First submitted
- 15 Jan 2024
- Start date
- 26 Jun 2019
- Primary completion date
- 1 Jun 2023
- Lead sponsor
- Medecins Sans Frontieres, Spain
- Diseases
- Tuberculosis
- NCT number
- NCT06239337
What you commit to
- Study type: Observational
- Participants enrolled: 563
- From 26 Jun 2019 to the primary completion date, 1 Jun 2023
- 2 sites in 2 countries
- 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.
Prior treatment
- Patients who have received TB treatment for \> 1 day in the last 3 months
- Patients not producing stools or urine during period of admission and prior to starting TB drugs
Who the study is looking for
- Any child from 6 months of life to 15 years old
- TB suspected according to diagnostic criteria
- Informed consent provided by legal responsible or companion
Age in the registry: 6 months to 15 years · Sex: All
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Simao Mendes hospital Coordinator of this site? Confirm its status | Bissau | Guinea-Bissau | Unknown status |
| Malakal hospital Coordinator of this site? Confirm its status | Malakal | South Sudan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.