FujiLAM Prospective Evaluation Trial

Foundation for Innovative New Diagnostics, Switzerland1,731 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

1,731

Conditions

Diagnosis of Tuberculosis in People Living With HIV

Interventions

Fujifilm SILVAMP TB LAMDEVICE

Fujifilm SILVAMP TB LAM detects the presence of lipoarabinomannan (LAM) in urine with a visually read lateral flow test that uses silver amplification.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Malawi-Liverpool-Wellcome Trust Clinical Research Programme

Blantyre, Malawi

CIDRI-Africa University of Cape Town

Cape Town, South Africa

Ifakara Health Institute

Dar es Salaam, Tanzania

The HIV Netherlands Australia Thailand Research collaboration

Bangkok, Bankok, Thailand

Outcomes

Primary Outcomes

Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined eMRS.

Time frame: Day 1

Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined CRS.

Time frame: Day 1

Diagnostic yield, with 95% confidence interval, of FujiLAM test among eMRS positive patients and AlereLAM, Smear and Ultra (sputum, urine) as comparators (on Day 1 specimens).

Time frame: Day 1

Data from ClinicalTrials.gov

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