Clinical trial NCT05036694: Diagnostic Performance of a Novel Lipoarabinomannan.
Official title: Diagnostic Performance of a Novel Lipoarabinomannan Test (FujiLAM) to Detect Tuberculosis in HIV-positive Patients in Kenya
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Primary Infection
Keywords: TUBERCULOSIS IN HIV
Lead sponsor: Médecins Sans Frontières, Kenya
Sponsor class: OTHER
Collaborators: name: Epicentre
First posted: 2021-09-08
Enrollment: 550
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: GROUP 1_ TB SYMPTOMS GROUP2_ ADVANCED HIV WITH NO TB SYMPTOMS
Primary purpose: DIAGNOSTIC

Brief summary: 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To investigate the diagnostic performance of FujiLAM in ambulatory HIV positive patients.
timeFrame: 12 months
Secondary outcomes:
measure: To assess the sensitivity of FujiLAM at different levels of CD4 count.
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: MEDECIN SAN FRONTIERES
name: HELENA DR Coordinating Principal Investigator, PhD
role: PRINCIPAL_INVESTIGATOR
References: