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FujiLAM Prospective Evaluation Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04089423
Recruitment Status : Not yet recruiting
First Posted : September 13, 2019
Last Update Posted : September 17, 2019
Sponsor:
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
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Diagnosis of Tuberculosis in People Living With HIV Device: Fujifilm SILVAMP TB LAM

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Fujifilm SILVAMP TB LAM
    Fujifilm SILVAMP TB LAM detects the presence of lipoarabinomannan (LAM) in urine with a visually read lateral flow test that uses silver amplification.
    Other Name: Omega VISITECT® CD4 Advanced Disease test


Primary Outcome Measures :
  1. Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined eMRS. [ Time Frame: Day 1 ]
  2. Point estimates of sensitivity and specificity of FujiLAM, with 95% confidence intervals, using the defined CRS. [ Time Frame: Day 1 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult people living with HIV
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.

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Responsible Party: Foundation for Innovative New Diagnostics, Switzerland
ClinicalTrials.gov Identifier: NCT04089423    
Other Study ID Numbers: 7430-2/1
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Foundation for Innovative New Diagnostics, Switzerland:
tuberculosis, PLHIV
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections