FujiLAM Prospective Evaluation Trial

Completed

• Conditions: Diagnosis of Tuberculosis in People Living With HIV

• Registration Number: NCT04089423
• Lead Sponsor: Foundation for Innovative New Diagnostics, Switzerland

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2019-09-12
• Study First Posted: 2019-09-13
• Study Start: 2019-12-13
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-24
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1731

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined CRS.	Day 1
Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined eMRS.	Day 1

Trial Locations

Locations (7)

Infectious Diseases Institute; 🇺🇬 Kampala, Uganda

Viet Tiep Hospital; 🇻🇳 Hải Phòng, Le Chan, Vietnam

Centre for Infectious Disease Research in Zambia; 🇿🇲 Lusaka, Zambia

CIDRI-Africa University of Cape Town; 🇿🇦 Cape Town, South Africa

Ifakara Health Institute; 🇹🇿 Dar es Salaam, Tanzania

Malawi-Liverpool-Wellcome Trust Clinical Research Programme; 🇲🇼 Blantyre, Malawi

The HIV Netherlands Australia Thailand Research collaboration; 🇹🇭 Bangkok, Bankok, Thailand