Status:
ENROLLING_BY_INVITATION
Evaluation of New TB Diagnostic Tests (NATs) in Pakistan
Lead Sponsor:
Mercy Corps Pakistan
Collaborating Sponsors:
Centre for Global Public Health Pakistan
Royal Tropical Institute
Conditions:
Tuberculosis Diagnosis
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
This study aims to test new diagnostic methods for tuberculosis (TB) testing as compared to the existing Xpert MTB/Rif Ultra testing approach. The research questions that will be addressed by this stu...
Detailed Description
Research Objective 1: The study aims to assess the diagnostic accuracy-specifically the sensitivity and specificity-of two new NAT-based tuberculosis (TB) tests, Pluslife and Ustar. These tests will ...
Eligibility Criteria
Inclusion
- People who are screened for TB on X-ray with CAD and their CAD scores are available
- Age range appropriate for the test (e.g., adult patients 12 yrs old and above)
- Any gender
- Consent to participate in the study and provide samples (e.g., tongue swab, sputum).
Exclusion
- Pregnant women (depending on the diagnostic method or potential risks involved).
- Known cases of Pulmonary TB
- People who are unable to produce sputum
- Extra Pulmonary TB cases
- People who are not screened for TB on X-ray and/or their CAD scores are not available
Key Trial Info
Start Date :
December 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2026
Estimated Enrollment :
6100 Patients enrolled
Trial Details
Trial ID
NCT06984887
Start Date
December 19 2025
End Date
August 30 2026
Last Update
January 2 2026
Active Locations (1)
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1
National Reference Laboratory
Islamabad, Federal Capital, Pakistan, 44000