Status:

ACTIVE_NOT_RECRUITING

Evaluation of a Rapid Point-of-Care Serological Triage Test for Active TB

Lead Sponsor:

Norwegian Institute of Public Health

Collaborating Sponsors:

European and Developing Countries Clinical Trials Partnership (EDCTP)

University of Stellenbosch

Conditions:

Tuberculosis, Pulmonary

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The performance of a new triage test for active tuberculosis (TB), SeroSelectTB, will be qualified in multi-centre randomised controlled trials at health-posts in South Africa, Tanzania and Ethiopia. ...

Detailed Description

Purpose: Worldwide over 15 million persons live with active TB. While the prevalence of latent TB is very high, only disease, and not latent infection, is treated in most high burdened countries. A r...

Eligibility Criteria

Inclusion

  • 18 years of age or older
  • Informed Consent Form signed
  • Unwell, suspected to have TB or pneumonia

Exclusion

  • Currently receiving TB treatment
  • On TB treatment past 30 days or more, or last dose less than 1 month before enrolment

Key Trial Info

Start Date :

September 21 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2025

Estimated Enrollment :

9097 Patients enrolled

Trial Details

Trial ID

NCT04752592

Start Date

September 21 2021

End Date

December 31 2025

Last Update

October 1 2025

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Amhara region

Bahir Dar, Ethiopia

2

Stellenbosch University Clinics

Cape Town, Western Cape, South Africa, 7505

3

Kilimanjaro region, Tanzania

Moshi, Tanzania