Diagnostic Performance of a Novel Lipoarabinomannan. (FUJILAM)

Diagnostic Performance of a Novel Lipoarabinomannan Test (FujiLAM) to Detect Tuberculosis in HIV-positive Patients in Kenya

The Fujifilm SILVAMP TB LAM (FujiLAM; Fujifilm, Tokyo, Japan) is a novel (not commercialized) urine based point-of-care assay to diagnose TB in HIV-positive patients. A first study using urine frozen samples has reported a higher sensitivity of this test over the currently commercialised Alere Determine TB LAM Ag assay (AlereLAM).

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Primary Infection
• Intervention / Treatment: Device: FUJILAM KIT

Detailed Description

The study aims to assess the performance of a new test called the Fujifilm SILVAMP TB LAM or simply the Fuji-LAM test. The Fuji-LAM test is a test that can be done on urine to look for specific proteins that are produced by the bacteria that causes tuberculosis. This test offers an advantage over the tests that are based on phlegm because most patients can produce urine for testing even when they are very sick. Additionally, this test does not require a complex laboratory set up and it can therefore be used by health workers as they interact with the patient. This study will also look at how the new test compares with an existing test AlereLAM - that is based on similar technology. Initial laboratory-based studies conducted on frozen urine samples show that the new test has better performance than the existing test. This study is different from the first studies because it is being conducted in real life settings rather than in a laboratory.

The study will be conducted at the Homa Bay County Hospital in Kenya. Individuals living with HIV with and without signs and symptoms of TB will be invited to take part. Individuals who agree to participate will be seen by the health workers in the study and will provide samples for testing using the FujiLAM test and other standard tests used to investigate individuals for suspected tuberculosis.

Investigators are also conducting similar studies in other African countries including Uganda, Mozambique and South Africa. This will enable investigators to assess the performance of the test in diverse settings.

• Study Type: Interventional
• Enrollment (Anticipated): 550
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: HELENA DR Coordinating Principal Investigator, PhD; Phone Number: +32493837895; Email: Helena.HUERGA@epicentre.msf.org
• Study Contact Backup: Name: STEPHEN DR Site Principal Investigator, MPH; Phone Number: +254720284862; Email: wansiste07@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 15 years of age or older
• HIV-positive Group 1: At least one symptom of TB

Group 2:

• Advanced HIV disease (CD4 count less than 200cell/µl or clinical stage III/IV)
• No signs and symptoms of TB
• Signature of the informed consent

Exclusion Criteria:

• Intake of anti-tuberculosis drugs for more than 5 days in the month prior to the consultation except preventive TB treatment.
• Decline to sign informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Ambulatory HIV positive patients; Ambulatory HIV positive patients with signs and symptoms of TB, and Ambulatory HIV positive patients with advanced disease and CD4 less than 200 cell.	Device: FUJILAM KIT; Urine based test to detect LAM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate the diagnostic performance of FujiLAM in ambulatory HIV positive patients.	Proportion of patients with a positive FujiLAM result among patients with microbiologically confirmed TB in ambulatory HIV-positive patients with signs and symptoms of TB (Group 1) and Diagnostic performance of FujiLAM test to detect tuberculosis in HIV-positive patients in Kenya - Protocol v2.3 14 in ambulatory HIV-positive patients with advanced HIV disease and no signs and symptoms of TB (Group 2).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the sensitivity of FujiLAM at different levels of CD4 count.	Proportion of patients with a positive FujiLAM result among patients with probable TB or microbiologically confirmed TB in ambulatory HIV-positive patients with signs and symptoms of TB (Group 1) and in ambulatory HIV-positive patients with advanced HIV disease and no signs and symptoms of TB (Group 2).; Proportion of patients with a positive FujiLAM result among patients with microbiologically confirmed TB and among patients with probable TB or microbiologically confirmed TB by level CD4.; Proportion of patients with a positive AlereLAM among patients with microbiologically confirmed; TB and among patients with probable TB or microbiologically confirmed TB by level of CD4.	12 months

Collaborators and Investigators

• Sponsor: Médecins Sans Frontières, Kenya
• Collaborators: Epicentre
• Investigators: Principal Investigator: HELENA DR Coordinating Principal Investigator, PhD, MEDECIN SAN FRONTIERES

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (ACTUAL): September 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 8, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: TUBERCULOSIS IN HIV
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: ANRS12429

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No