Status:
COMPLETED
FujiLAM Prospective Evaluation Trial
Lead Sponsor:
Foundation for Innovative New Diagnostics, Switzerland
Collaborating Sponsors:
Centre for Infectious Disease Research in Zambia
Infectious Diseases Institute, Uganda
Conditions:
Diagnosis of Tuberculosis in People Living With HIV
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective, multicentre cohort study in which the accuracy and the diagnostic yield of the FujiLAM test will be assessed using a microbiological reference standard, an extended microbiologi...
Eligibility Criteria
Inclusion
- Adult PLHIV (≥18 years), irrespective of their CD4 count and antiretroviral therapy (ART) status, at risk of having pulmonary and/or extra-pulmonary TB
- Inpatients: irrespective of TB symptoms
- Outpatients: at least one of the symptoms suggestive of TB (as defined by WHO\*)
- written informed consent
- willingness to have a trial follow-up visit at 2-3 and 6 months after enrolment (e.g. not planning to relocate)
Exclusion
- Current anti-TB treatment \*
- Any anti-TB treatment within 60 days prior to enrolment
- Any isoniazid preventive therapy within 6 months prior to enrolment \* Patients starting anti-TB treatment at the time of enrolment will not be excluded from the trial provided that all trial specimens are collected before starting the 3rd dose of treatment.
Key Trial Info
Start Date :
December 13 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
1731 Patients enrolled
Trial Details
Trial ID
NCT04089423
Start Date
December 13 2019
End Date
December 31 2021
Last Update
January 25 2022
Active Locations (7)
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1
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Blantyre, Malawi, Box 30096
2
CIDRI-Africa University of Cape Town
Cape Town, South Africa, 7925
3
Ifakara Health Institute
Dar es Salaam, Tanzania, Box 78 373
4
The HIV Netherlands Australia Thailand Research collaboration
Bangkok, Bankok, Thailand