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+ TRIAL
Undetected TB in African communities remains a major public health problem, resulting in prolonged infectiousness and disease transmission, increased risk of suffering and mortality due to delayed initiation of treatment, serious health sequelae, and catastrophic financial consequences.
The innovative TB TRIAGE+ TRIAL is investigating novel community-based strategies to actively detect TB.
In overall 20’000 people from Lesotho and KwaZulu-Natal, we will use a paired screen-positive design to test the hypothesis that a community-based active TB case-finding strategy with CAD4TB screening in combination with a point point-of-care C-reactive protein triage test will be non-inferior to CAD4TB screening alone in terms of yield of TB cases detected and superior in terms of cost-effectiveness.
In addition, the TB TRIAGE+ TRIAL will also address broader health economics issues, explore the feasibility of introducing the
expanded HIV care package in community health campaigns, and examine the
utility of ultra-portable x-ray equipment.
Both trials will be registered on ClinicalTrials.gov.