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Point-of-care Triage Test for Active Tuberculosis

NCT04232618 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 900

Last updated 2022-01-25

No results posted yet for this study

Summary

Background:

Tuberculosis (TB) is a bacterial lung infection leaving 3.6 million people undiagnosed each year. Thirty percent of infected people do not receive treatment due to failure to receive diagnostic testing or being lost to follow-up between testing and availability of results.

Objective:

To refine and field-validate a point-of-care (POC) finger stick blood test for use worldwide to triage for active TB.

Eligibility:

Persons aged 12 - 70 years with symptoms suggestive of TB disease

Study design:

Participants will be screened with:

Medical history Physical exam HIV test, diabetes screening Blood (finger stick and venous), sputum and urine collection Chest X-ray TB positive participants will receive treatment from the National TB Program at Community Health Centres and clinics.

Conditions

Interventions

DIAGNOSTIC_TEST

Multi-biomarker point-of-care test

Lateral flow device containing a combination of markers which have been shown to be associated with active tuberculosis.

Sponsors & Collaborators

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • Makerere University

    collaborator OTHER

  • Find

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • Medical Research Council Unit, The Gambia

    collaborator OTHER

  • LINQ Management GMBH

    collaborator UNKNOWN

  • University of Stellenbosch

    lead OTHER

Principal Investigators

  • Gerhard Walzl, MBCHB; PhD · University of Stellenbosch

Eligibility

Min Age
15 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-05
Primary Completion
2023-09-30
Completion
2024-03-31

Countries

  • South Africa

Study Locations

More Related Trials

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 NCT04232618 on ClinicalTrials.gov