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Stool Processing Kit (SPK) Evaluation for Pediatric Tuberculosis (TB)

NCT04899076 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2023-11-24

No results posted yet for this study

Summary

This is a prospective, multicenter cohort study in which the accuracy and the diagnostic yield of the Stool Processing Kit (SPK) in combination with Xpert Ultra MTB/RIF (Ultra) on stool samples will be assessed using a microbiological reference standard and a composite reference standard among children with signs and symptoms of pulmonary tuberculosis.

Conditions

Interventions

DEVICE

Stool Processing Kit

The Stool Processing Kit is a centrifuge-free stool processing solution that allows preparation of stool samples for testing with the Xpert Ultra MTB/RIF assay

Sponsors & Collaborators

  • Mulago Hospital, Uganda

    collaborator OTHER

  • University of Cape Town Lung Institute

    collaborator OTHER

  • University of California, San Francisco

    collaborator OTHER

  • All India Institute of Medical Sciences

    collaborator OTHER

  • KEM Hospital Research Centre

    collaborator OTHER

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Principal Investigators

  • Morten Ruhwald, MD · Find

Eligibility

Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-19
Primary Completion
2021-03-31
Completion
2021-10-31

Countries

  • India
  • South Africa
  • Uganda

Study Locations

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Entities

Diseases
Companies

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 NCT04899076 on ClinicalTrials.gov