FujiLAM Prospective Evaluation Trial

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

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 Overview

• Status: Completed
• Conditions: Diagnosis of Tuberculosis in People Living With HIV
• Intervention / Treatment: Device: Fujifilm SILVAMP TB LAM

• Study Type: Observational
• Enrollment (Actual): 1731

Contacts and Locations

Study Locations

• Malawi
  • Blantyre, Malawi, Box 30096
    • Malawi-Liverpool-Wellcome Trust Clinical Research Programme
• South Africa
  • Cape Town, South Africa, 7925
    • CIDRI-Africa University of Cape Town
• Tanzania
  • Dar es Salaam, Tanzania, Box 78 373
    • Ifakara Health Institute
• Thailand
  • Bankok
    • Bangkok, Bankok, Thailand
      • The HIV Netherlands Australia Thailand Research Collaboration
• Uganda
  • Kampala, Uganda, Box 22418
    • Infectious Diseases Institute
• Vietnam
  • Le Chan
    • Hải Phòng, Le Chan, Vietnam
      • Viet Tiep Hospital
• Zambia
  • Lusaka, Zambia, 34620
    • Centre for Infectious Disease Research in Zambia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult people living with HIV

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined eMRS.	Day 1
Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined CRS.	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).	Day 1

Collaborators and Investigators

• Sponsor: Foundation for Innovative New Diagnostics, Switzerland
• Collaborators: Swiss Tropical & Public Health Institute; University of Cape Town; The HIV Netherlands Australia Thailand Research Collaboration; Ifakara Health Institute; Centre for Infectious Disease Research in Zambia; Malawi-Liverpool-Wellcome Trust Clinical Research Programme; Infectious Diseases Institute, Uganda; Viet-Tiep Hospital; National Tuberculosis Control Programme; Fujifilm; Omega Diagnostics; Tuberculosis and Lung Disease Hospital in Hai Phong
• Investigators: Principal Investigator: Morten Ruhwald, MD, FIND Head of TB programme

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 13, 2019

Study Record Updates

• Last Update Posted (Actual): January 25, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: tuberculosis, PLHIV
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Disease; Tuberculosis
• Other Study ID Numbers: 7430-2/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No