Diagnosis of Tuberculosis in People Living With HIVNCT04089423
FujiLAM Prospective Evaluation Trial
An observational study of Diagnosis of Tuberculosis in People Living With HIV, run by Foundation for Innovative New Diagnostics, Switzerland at 7 sites in 7 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diagnosis of Tuberculosis in People Living With HIV
- What is being tested?
- Fujifilm SILVAMP TB LAM
- Type of treatment
- Medical device
- How many people
- 1,731 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 13 Dec 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult people living with HIV
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
Malawi1 site
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Blantyre, Box 30096
Thailand1 site
The HIV Netherlands Australia Thailand Research collaboration
Bangkok, Bankok
About this study
Official 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
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).
- Being tested
- Fujifilm SILVAMP TB LAM
- Keywords
- tuberculosis, PLHIV
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fujifilm SILVAMP TB LAMDevice
Also called Omega VISITECT® CD4 Advanced Disease test
Fujifilm SILVAMP TB LAM detects the presence of lipoarabinomannan (LAM) in urine with a visually read lateral flow test that uses silver amplification.
What is being measured
The primary outcome is the main question the study is designed to answer.
Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined eMRS.
Measured: Day 1
Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined CRS.
Measured: 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).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start13 Dec 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diagnosis of Tuberculosis in People Living With HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,731 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Centre 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
- Responsible party
- Sponsor
- Investigators
- Morten Ruhwald, MD, Principal investigator, FIND Head of TB programme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089423
- Sponsor's protocol ID
- 7430-2/1
- Status last verified
- Jan 2022
- First submitted
- 12 Sep 2019
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39577975Gils 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.
PubMed 39046150Szekely 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.
PubMed 38820372
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04089423
- Acronym / sponsor ID
- 7430-2/1
- Keywords
- tuberculosis, PLHIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,731 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Collaborators
- Centre 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
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult people living with HIV
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fujifilm SILVAMP TB LAMAlso: Omega VISITECT® CD4 Advanced Disease testFujifilm SILVAMP TB LAM detects the presence of lipoarabinomannan (LAM) in urine with a visually read lateral flow test that uses silver amplification. | Device | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Derived from this study: PubMed 39577975Sossen 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.
- Derived from this study: PubMed 39046150Gils 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.
- Derived from this study: PubMed 38820372Szekely 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.
- Individual participant dataSharing planned: No
Related trials for Diagnosis of Tuberculosis in People Living With HIV
Active, not recruitingPhase 4
Comparing Treatment Completion Of Daily Rifapentine & Isoniazid For One Month (1HP) To Weekly High Dose Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in Household Contacts of Recently Diagnosed Tuberculosis Patients
HIV Seropositivity, Tuberculosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten Ruhwald, MD principal investigator
FIND Head of TB programme
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnosis of Tuberculosis in People Living With HIV, run by Foundation for Innovative New Diagnostics, Switzerland at 7 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Malawi, South Africa, Tanzania, Thailand, Uganda and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined eMRS. (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04089423, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.