CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,731 enrolled
Drug / intervention
Fujifilm SILVAMP TB LAMdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04089423
NCT04089423N/ACompleted
CompareCT.gov

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

Foundation for Innovative New Diagnostics, Switzerland·observational·Posted Sep 13, 2019·Updated Jan 25, 2022

In Brief

An observational study evaluating Fujifilm SILVAMP TB LAM for Diagnosis of Tuberculosis in People Living With HIV. Completed, enrolled 1,731 participants across 7 sites in 7 countries.

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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsDiagnosis of Tuberculosis in People Living With HIV
CountriesMalawi, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia
CollaboratorsCentre for Infectious Disease Research in Zambia, Infectious Diseases Institute, Uganda, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Swiss Tropical & Public Health Institute, Ifakara Health Institute, University of Cape Town, Viet Tiep Hospital, National Tuberculosis Control Programme, Fujifilm, Omega Diagnostics, Tuberculosis and Lung Disease Hospital in Hai Phong, The HIV Netherlands Australia Thailand Research Collaboration

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 13, 2019
Enrollment StartDec 13, 2019
Primary CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.8 years ago

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.