Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa

NACompletedINTERVENTIONAL
Enrollment

20,000

Participants

Timeline

Start Date

September 7, 2022

Primary Completion Date

December 10, 2024

Study Completion Date

December 31, 2024

Conditions
Tuberculosis
Interventions
DIAGNOSTIC_TEST

CAD4TB

A posterior anterior digital chest X-ray incoporated in a mobile diagnostic unit is analysed by CAD4TB version 7 (Delft Imaging, NL). A trained and qualified person in compliance with national regulations will operate the digital chest X-ray.

DIAGNOSTIC_TEST

POC-CRP

A quantitative POC-CRP LumiraDx (LumiraDx Limited, UK) triage test will be performed by finger-prick if CAD4TB scores is within the defined threshold window of study approach 2 triage testing

DIAGNOSTIC_TEST

Xpert MTB/RIF Ultra

Depending on CAD4TB (approach 1 \& 2) or POC-CRP score (approach 2) a confirmatory Xpert MTB/RIF Ultra(Cepheid, USA) rapid sputum molecular testing follows for both Mycobacterium tuberculosis complex and rifampicin resistance;

Trial Locations (2)

Unknown

SolidarMed, Maseru

Human Sciences Research Council, Pietermaritzburg

All Listed Sponsors
collaborator

SolidarMed

OTHER

collaborator

Institute of Tropical Medicine, Belgium

OTHER

collaborator

Radboud University Medical Center

OTHER

collaborator

Charite University, Berlin, Germany

OTHER

collaborator

Human Sciences Research Council

OTHER_GOV

lead

Klaus Reither

OTHER