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FujiLAM Prospective Evaluation Trial

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ClinicalTrials.gov Identifier: NCT04089423
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : March 17, 2020
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

Tracking Information
First Submitted Date September 12, 2019
First Posted Date September 13, 2019
Last Update Posted Date March 17, 2020
Actual Study Start Date December 13, 2019
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 12, 2019)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adult people living with HIV
Condition Diagnosis of Tuberculosis in People Living With HIV
Intervention 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 12, 2019)
1200
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Rita Szekely, PhD +41-22-749-2932 rita.szekely@finddx.org
Contact: Pamela Nabeta, MD +41-22-710-0590 pamela.nabeta@finddx.org
Listed Location Countries Malawi,   South Africa
Removed Location Countries  
 
Administrative Information
NCT Number NCT04089423
Other Study ID Numbers 7430-2/1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Foundation for Innovative New Diagnostics, Switzerland
Study Sponsor Foundation for Innovative New Diagnostics, Switzerland
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
Investigators
Principal Investigator: Morten Ruhwald, MD FIND Head of TB programme
PRS Account Foundation for Innovative New Diagnostics, Switzerland
Verification Date September 2019