FujiLAM Prospective Evaluation Trial

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).

Completed

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Key information

Conditions

Diagnosis of Tuberculosis in People Living With HIV Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fujifilm SILVAMP TB LAM

Device

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

Other names: Omega VISITECT® CD4 Advanced Disease test

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

Sponsors and collaborators

Lead sponsor

Foundation for Innovative New Diagnostics, Switzerland

Other

Collaborators

Centre for Infectious Disease Research in Zambia
Fujifilm
Ifakara Health Institute
Infectious Diseases Institute, Uganda
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
National Tuberculosis Control Programme
Omega Diagnostics
Swiss Tropical & Public Health Institute
The HIV Netherlands Australia Thailand Research Collaboration
Tuberculosis and Lung Disease Hospital in Hai Phong
University of Cape Town
Viet Tiep Hospital

Registry information

Official study title

Prospective Multicentre Evaluation of the Accuracy and Diagnostic Yield of the Fujifilm SILVAMP TB LAM (FujiLAM) Test for the Diagnosis of Tuberculosis in People Living With HIV

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Sep 13, 2019
Registry last updated: Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed