Same Day Diagnosis of Extrapulmonary TB (TB Serositis and TB Meningitis).

Launched by UNIVERSITY OF CAPE TOWN · Nov 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new test called the IRISA-TB assay, which is designed to help doctors quickly and accurately diagnose extrapulmonary tuberculosis (EPTB). EPTB is a type of tuberculosis that occurs outside the lungs and can affect different parts of the body, such as the fluid around the lungs, heart, or brain. Current tests for diagnosing EPTB can be unreliable and often require invasive procedures, like biopsies. The trial will compare the performance of the IRISA-TB test with existing methods to see how well it works in patients suspected of having EPTB, including those with pleural effusion, pericardial effusion, peritonitis, and meningitis.

To participate in this trial, you need to be 18 years or older and have symptoms of tuberculosis. You should be attending a healthcare facility and able to provide a fluid sample for testing. The study will involve around 2,000 participants, and researchers will also gather feedback from doctors about how helpful the IRISA-TB test is for making treatment decisions. If you join the trial, you can expect to undergo the new test along with standard tests, and your participation might contribute to finding a faster and easier way to diagnose EPTB, potentially saving costs for patients and the healthcare system.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female participants 18 years and over attending health care facility with symptoms of TB.
• • 2. Serosal or CSF fluid sample provided to NHLS with sufficient volume to perform SOC tests + 1ml.
• • 3. Patients in whom extrapulmonary TB is part of the treating clinicians' differential diagnosis.
• Exclusion Criteria:
• • 1. Volunteers who refuse to sign informed consent and/or provide clinical details (Proxy consent will be obtained for participants who are incapacitated, with a follow up consent when they have recovered their capacity to consent)
• • 2. Patients with current significant history of substance or alcohol abuse that may impact study visits.
• • 3. Patients who are unable to communicate by telephone or who do not have a current active traceable contact number.
• • 4. Patients not willing to undergo an HIV test.
• • 5. Patients whose fluid sample volumes are insufficient to perform standard of care testing in addition to IRISA-TB
• • 6. Positive sputum GXP within 2 weeks prior to serosal fluid or CSF sampling.