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Evaluation of Xpert MTB/RIF Ultra in Stools and Urine to Improve Tuberculosis Diagnosis in Children

NCT06239337 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 563

Last updated 2024-02-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Xpert MTB/RIF Ultra in stools and urine

All children with presumptive TB had at least 1 sample collected of respiratory or extrapulmonary specimen (considered as gold standard) and 1 sample of stools and 1 sample of urine. All of them were analyzed with Xpert MTB/RIF Ultra.

Sponsors & Collaborators

  • Ministry of Health, Guinea-Bissau

    collaborator UNKNOWN

  • Ministry of Health, South Sudan

    collaborator UNKNOWN

  • Institute of Tropical Medicine, University of Tuebingen

    collaborator OTHER

  • Medecins Sans Frontieres, Spain

    lead OTHER

Principal Investigators

  • Laura Moretó Planas, MD · MSF OCBA

Eligibility

Min Age
6 Months
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-26
Primary Completion
2023-06-01
Completion
2023-12-15

Countries

  • Guinea-Bissau
  • South Sudan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06239337 on ClinicalTrials.gov