Status:
ACTIVE_NOT_RECRUITING
Evaluation of the Truenat™MTB Plus/COVID-19 Test for TB (Tuberculosis) and COVID-19 (SARS-CoV2)
Lead Sponsor:
Foundation for Innovative New Diagnostics, Switzerland
Conditions:
TB
COVID-19
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective, multicentre study in which the accuracy of the Molbio Diagnostics Truenat™ MTB (Mycobacterium tuberculosis) Plus/COVID-19multiplex will be assessed for TB and COVID-19 case dete...
Detailed Description
Adult patient with presumptive TB will be screened for inclusion at 4 geographically diverse participating centres in high TB burden countries. This will be the first large scale evaluation on prospec...
Eligibility Criteria
Inclusion
- Adult (≥18 years); and
- Able to provide written informed consent in their chosen language; and
- Self-report at least one or more symptoms suggestive of pulmonary TB\*; and
- Willing to return for a day 2 visit
- Willing to provide oral swab samples for biobanking \* cough ≥2 weeks, fever, night sweats or unintended weight-loss
Exclusion
- Any tuberculosis preventive therapy (TPT) within 6 months prior to enrolment
- Any anti-TB treatment within 60 days prior to enrolment (not current episode)
- Unable to provide 3ml of sputum, nasopharyngeal and tongue swabs on Day1
- Unable to provide all study samples before starting the 3rddose of anti-TB treatment.
Key Trial Info
Start Date :
August 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
1480 Patients enrolled
Trial Details
Trial ID
NCT05405296
Start Date
August 30 2022
End Date
September 1 2024
Last Update
January 18 2024
Active Locations (1)
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1
Makarere University
Kampala, Uganda