Status:
COMPLETED
Diagnostic Accuracy of CAD4TB and C-reactive Protein Assay as Triage Tests for Pulmonary Tuberculosis
Lead Sponsor:
Klaus Reither
Collaborating Sponsors:
SolidarMed
Human Sciences Research Council
Conditions:
Pulmonary Tuberculosis
Tuberculosis Diagnosis
Eligibility:
All Genders
18+ years
Brief Summary
In the TB TRIAGE+ ACCURACY study, the accuracy of the following products will be determined: * CAD4TB (Delft Imaging System, NL), a digital chest x-ray analysis software * Afinion CRP assay (Alere Af...
Detailed Description
This is a prospective, partially blinded, two-centre cross-sectional study in which the diagnostic test accuracy of CAD4TB and an Afinion CRP assay test for TB will be assessed at facility level by ev...
Eligibility Criteria
Inclusion
- Willing and able to provide signed written consent or witnessed oral consent in the case of illiteracy, prior to undertaking any study-related procedure
- Adults (≥18 years)
- Any of the cardinal symptoms of TB (cough, weight loss, night sweats, fever) of any duration
Exclusion
- Pregnancy (based on oral information from participant)
- Any condition for which participation in the study, as judged by the investigator, could compromise the well-being of the subject or prevent, limit or confound protocol specified assessments
- Critically sick patients who need immediate medical care
- Current anti-TB treatment
Key Trial Info
Start Date :
February 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 11 2022
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT04666311
Start Date
February 15 2021
End Date
August 11 2022
Last Update
September 22 2025
Active Locations (2)
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1
Butha-Buthe District Hospital
Butha-Buthe, Lesotho
2
Caluza Clinic
Pietermaritzburg, KwaZulu-Natal, South Africa