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

CompletedOBSERVATIONAL
Enrollment

969

Participants

Timeline

Start Date

April 1, 2016

Primary Completion Date

April 30, 2019

Study Completion Date

July 31, 2020

Conditions
Pulmonary Tuberculosis
Interventions
DIAGNOSTIC_TEST

Trans-Dot point-of-care test

"Training set participants will be recruited and receive investigations for TB. Blood samples will also be collected from them for performance of ELISAs and laboratory-based TransDot tests. These blood samples will be drawn at baseline, week 8 and week 24 at end of treatment for confirmed TB cases and at baseline for non-TB cases.~Test set participants will be recruited and receive investigations for TB. A POC TransDot test will be performed on fingerprick blood at baseline, and at week 8 and week 24 in participants on TB treatment, as well as a laboratory based TransDot test on serum at baseline. The week 8 and week 24 TransDot tests will be used to investigate the test's utility as an indicator of treatment response."

Trial Locations (10)

7505

Stellenbosch University, Cape Town

13301

University of Namibia, Windhoek

14057

LINQ Management GmbH, Berlin

66123

European Research and Project Office GmbH, Saarbrücken

Unknown

Armauer Hansen Research Institute, Addis Ababa

Medical Research Council The Gambia, Banjul

Makerere University, Kampala

2593 HW

The European & Developing Countries Clinical Trials Partnership Association (EDCTP), The Hague

2333 ZA

Leiden University Medical Center (Academisch Ziekenhuis Leiden, LUMC), Leiden

WC1E 7HT

London School of Hygiene and Tropical Medicine, London

All Listed Sponsors
collaborator

Armauer Hansen Research Institute, Ethiopia

OTHER

collaborator

Medical Research Council Unit, The Gambia

OTHER

collaborator

Leiden University Medical Center

OTHER

collaborator

Makerere University

OTHER

collaborator

London School of Hygiene and Tropical Medicine

OTHER

collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

collaborator

LINQ Management GMBH

UNKNOWN

lead

Prof Gerhard Walzl

OTHER

NCT03350048 - Evaluation of Host Biomarker-based Point-of-care Tests for Targeted Screening for Active TB | Biotech Hunter | Biotech Hunter