Clinical trial NCT04089423: FujiLAM Prospective Evaluation Trial
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnosis of Tuberculosis in People Living With HIV
Keywords: tuberculosis, PLHIV
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
Collaborators: name: Centre for Infectious Disease Research in Zambia
name: Infectious Diseases Institute, Uganda
name: Malawi-Liverpool-Wellcome Trust Clinical Research Programme
name: Swiss Tropical & Public Health Institute
name: Ifakara Health Institute
name: University of Cape Town
name: Viet Tiep Hospital
name: National Tuberculosis Control Programme
name: Fujifilm
name: Omega Diagnostics
name: Tuberculosis and Lung Disease Hospital in Hai Phong
name: The HIV Netherlands Australia Thailand Research Collaboration
First posted: 2019-09-13
Enrollment: 1731
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult people living with HIV

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined eMRS.
timeFrame: Day 1
measure: Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined CRS.
timeFrame: Day 1
measure: 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).
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Malawi-Liverpool-Wellcome Trust Clinical Research Programme
city: Cape Town
country: South Africa
facility: CIDRI-Africa University of Cape Town
city: Dar es Salaam
country: Tanzania
facility: Ifakara Health Institute
city: Bangkok
country: Thailand
facility: The HIV Netherlands Australia Thailand Research collaboration
state: Bankok
city: Kampala
country: Uganda
facility: Infectious Diseases Institute
city: Hải Phòng
country: Vietnam
facility: Viet Tiep Hospital
state: Le Chan
city: Lusaka
country: Zambia
facility: Centre for Infectious Disease Research in Zambia
Study officials:
affiliation: FIND Head of TB programme
name: Morten Ruhwald, MD
role: PRINCIPAL_INVESTIGATOR
References: