Clinical Trial #1:
TB TRIAGE+ ACCURACY
Prospective evaluation of the accuracy of CAD4TB and a point-of-care C-reactive protein assay as triage test for diagnosis of pulmonary tuberculosis.
In total, 1400 adult presumptive TB patients attending a health facility in Lesotho (Butha Buthe District; n=700) or in KwaZulu-Natal (Umgungundlovu District; n=700) will be included after informed consent. Presumptive TB patients should have one or more TB symptoms according to WHO recommended four-symptom screening of any duration (cough, weight loss, night sweats, fever).
The TB TRIAGE+ ACCURACY trial will
- assess the diagnostic accuracy of CAD4TB and point-of-care C-reactive protein for the diagnosis of pulmonary TB
- help to define an optimal cut-off value for a TB screening algorithm to be used in community-based health campaigns.
Due to the coinciding pandemics and the overlapping symptoms of TB and COVID-19, it is critical to test for SARS-Cov-2 infections in the study population. In addition, we will evaluate a novel SARS-Cov-2 antigen rapid diagnostic test (from diagnostic pipeline of FIND) and CAD4COVID, a digital chest x-ray analysis software (Delft Imaging System, NL) in combination with differential white blood cell count.
Clinical Trial #2:
TB TRIAGE+ RCT
Cluster-randomized controlled, open label, multicentre trial on CAD4TB and point-of-care CRP as TB triage test after TB symptom screening followed by confirmatory testing with Xpert MTB/RIF at community-level in Lesotho (Butha-Buthe and Mokhotlong districts) and KwaZulu-Natal (Sweetwaters community), South Africa.
Clusters of households are the units of randomisation. Cluster size will vary between 30 and 300 adult household members, with an expected average of 100. The total sample size is 35000 adult household members to be screened.
The TB TRIAGE+ RCT trial will
- investigate the effectiveness of a community-based TB testing algorithm consisting of WHO recommended four-symptom TB screening (cough, weight loss, night sweats, or fever; of any duration), mobile CAD4TB or point-of-care CRP triage test, on-site Xpert MTB/Rif rapid sputum molecular testing, and linkage to treatment compared to current standard-of-care in Lesotho and KwaZulu-Natal, South Africa.
- evaluate the cost-effectiveness and equity implication of the screening algorithms combining the results of the trial (TB TRIAGE+ RCT), secondary sources and modelling techniques to inform policy decisions.
Both trials will be registered on ClinicalTrials.gov.