FujiLAM Prospective Evaluation Trial

NCT04089423 | Completed

• 1 other identifier: 7430-2/1
• Study Type: observational
• Target: 1,731
• Locations: 6 countries
• Sites: 6

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).

Conditions

Diagnosis of Tuberculosis in People Living With HIV

Keywords

tuberculosis, PLHIV

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

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.

Also known as: Omega VISITECT® CD4 Advanced Disease test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult people living with HIV

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (7)

Malawi-Liverpool-Wellcome Trust Clinical Research Programme

Blantyre, Box 30096, Malawi

Location

CIDRI-Africa University of Cape Town

Cape Town, 7925, South Africa

Location

Ifakara Health Institute

Dar es Salaam, Box 78 373, Tanzania

Location

The HIV Netherlands Australia Thailand Research collaboration

Bangkok, Bankok, Thailand

Location

Infectious Diseases Institute

Kampala, Box 22418, Uganda

Location

Viet Tiep Hospital

Haiphong, Le Chan, Vietnam

Location

Centre for Infectious Disease Research in Zambia

Lusaka, 34620, Zambia

Location

Related Publications (3)

• Sossen B, Szekely R, Mukoka M, Muyoyeta M, Nakabugo E, Hella J, Van Nguyen H, Ubolyam S, Erkosar B, Vermeulen M, Centner CM, Nyangu S, Sanjase N, Sasamalo M, Dinh HT, Ngo TA, Manosuthi W, Jirajariyavej S, Nguyen NV, Avihingsanon A, Kerkhoff AD, Denkinger CM, Reither K, Nakiyingi L, MacPherson P, Meintjes G, Ruhwald M; FujiLAM Study Consortium. Urine-Xpert Ultra for the diagnosis of tuberculosis in people living with HIV: a prospective, multicentre, diagnostic accuracy study. Lancet Glob Health. 2024 Dec;12(12):e2024-2034. doi: 10.1016/S2214-109X(24)00357-7.

  PMID: 39577975 DERIVED

• Gils T, Hella J, Jacobs BKM, Sossen B, Mukoka M, Muyoyeta M, Nakabugo E, Van Nguyen H, Ubolyam S, Mace A, Vermeulen M, Nyangu S, Sanjase N, Sasamalo M, Dinh HT, Ngo TA, Manosuthi W, Jirajariyavej S, Denkinger CM, Nguyen NV, Avihingsanon A, Nakiyingi L, Szekely R, Kerkhoff AD, MacPherson P, Meintjes G, Reither K, Ruhwald M. A Prospective Evaluation of the Diagnostic Accuracy of the Point-of-Care VISITECT CD4 Advanced Disease Test in 7 Countries. J Infect Dis. 2025 Feb 4;231(1):e82-e90. doi: 10.1093/infdis/jiae374.

  PMID: 39046150 DERIVED

• Szekely R, Sossen B, Mukoka M, Muyoyeta M, Nakabugo E, Hella J, Nguyen HV, Ubolyam S, Chikamatsu K, Mace A, Vermeulen M, Centner CM, Nyangu S, Sanjase N, Sasamalo M, Dinh HT, Ngo TA, Manosuthi W, Jirajariyavej S, Mitarai S, Nguyen NV, Avihingsanon A, Reither K, Nakiyingi L, Kerkhoff AD, MacPherson P, Meintjes G, Denkinger CM, Ruhwald M; FujiLAM Study Consortium. Prospective multicentre accuracy evaluation of the FUJIFILM SILVAMP TB LAM test for the diagnosis of tuberculosis in people living with HIV demonstrates lot-to-lot variability. PLoS One. 2024 May 31;19(5):e0303846. doi: 10.1371/journal.pone.0303846. eCollection 2024.

  PMID: 38820372 DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Morten Ruhwald, MD

  FIND Head of TB programme

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 13, 2019
• Study Start: December 13, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 25, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1); MA (1); VN (1); ZA (1); TA (1); TH (1)