NCT03350048: ScreenTB

Evaluation of Host Biomarker-based Point-of-care Tests for Targeted Screening for Active TB

Completed Last updated 1 February 2023

What this trial tests

trial testing Trans-Dot point-of-care test in Pulmonary Tuberculosis in 969 participants. Completed in 31 July 2020.

Timeline

1 April 2016

Primary endpoint
30 April 2019

31 July 2020

Quick facts

Lead sponsor	Prof Gerhard Walzl
Status	Completed
Study type	OBSERVATIONAL
Enrollment	969
Start date	1 April 2016
Primary completion	30 April 2019
Estimated completion	31 July 2020
Sites	10 locations across Ethiopia, South Africa, Netherlands, Namibia, United Kingdom, Germany, The Gambia, Uganda

Drugs / interventions tested

• Trans-Dot point-of-care test

Conditions studied

• Pulmonary Tuberculosis — all drugs for Pulmonary Tuberculosis →

Sponsor

Prof Gerhard Walzl

Who can join

Adults 18 to 70, any sex, with Pulmonary Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Title: Evaluation of host biomarker-based point-of-care tests for targeted screening for active TB (Screen TB)

Introduction: Tuberculosis (TB) places severe pressure on health care services of the developing world. Despite the introduction of the highly sensitive and specific GeneXpert MTB/RIF (GeneXpert) test \[1\] with a potential turn-around time of two hours, many people in high TB prevalence areas still do not have access to efficient TB diagnostic services due to logistical constraints in these settings. A cost effective, rapid, point-of-care screening test with high sensitivity would identify people with a high likelihood for active TB and would prioritize them for testing with more expensive, technically or logistically demanding assays including GeneXpert or liquid culture, facilitating cost-effective diagnostic work-up in resource-limited settings. A serum cytokine signature for active TB disease, discovered in the AE-TBC project, with a sensitivity of 89% (CI 78 - 95%) and specificity of 76% (CI 68 - 83%), will be optimised and utilized in a point-of-care format (TransDot) to rapidly test for TB disease in symptomatic people.

Hypothesis: The TransDot test will achieve a sensitivity of \> 90% for TB disease, in a training set of people suspected of having TB disease, and be validated (achieve similarly high sensitivity) subsequently in a prospective test set of people suspected of having TB disease, when compared to a composite gold standard of sputum culture, smear, GeneXpert, chest X-ray, TB symptoms and TB treatment response.

Objectives: The overall objective of the study is to incorporate a six-marker serum signature into a multiplex UCP-LFA format, referred to as TransDot, for finger-prick blood testing. The end point of the study is the accuracy (sensitivity and specificity) of the UCP-LFA TransDot test on finger-prick blood for active TB and will be prospectively compared against gold standard composite diagnostic criteria (GeneXpert, MGIT culture, TB sputum smear, CXR, TB symptom screen and response to TB treatment).

Primary: The primary outcome of interest will be accuracy, sensitivity and specificity of the TransDot finger-prick test when compared with the composite gold standard tests.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Monocytic myeloid-derived suppressor cells reflect tuberculosis severity and are influenced by cyclooxygenase-2 inhibitors.
   Jøntvedt Jørgensen M, Jenum S, Tonby K, Mortensen R, et al · · 2021 · cited 15× · PMID 33155730 · DOI 10.1002/jlb.4a0720-409rr
2. PneumoniaCheck, a novel aerosol collection device, permits capture of airborne Mycobacterium tuberculosis and characterisation of the cough aeromicrobiome in people with tuberculosis.
   Chiyaka TL, Nyawo GR, Naidoo CC, Moodley S, et al · · 2024 · cited 5× · PMID 39175010 · DOI 10.1186/s12941-024-00735-x
3. Performance of 2 Finger-Stick Blood Tests to Triage Adults With Symptoms of Pulmonary Tuberculosis: A Prospective Multisite Diagnostic Accuracy Study.
   Sutherland JS, van der Spuy GD, Shaw JA, Richardson T, et al · · 2025 · cited 2× · PMID 40237453 · DOI 10.1093/cid/ciaf105
4. A novel aerosol collection method shows the cough aeromicrobiome of people with tuberculosis is phylogenetically distinct from respiratory tract specimens
   Chiyaka TL, Nyawo GR, Naidoo C, Moodley S, et al · · 2024 · DOI 10.21203/rs.3.rs-4106141/v1