FujiLAM Prospective Evaluation Trial

Foundation for Innovative New Diagnostics (FIND)

Status: Completed

Conditions: Diagnosis of Tuberculosis in People Living With HIV

Treatments: Device: Fujifilm SILVAMP TB LAM

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04089423

7430-2/1

Details and patient eligibility

About

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 microbiological reference standard and a composite reference standard among inpatient and outpatient people living with HIV (PLHIV).

Enrollment: 1,731 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.