NCT06135818

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,160 (estimated)
• Sponsor: University of Cape Town · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Extrapulmonary TB (EPTB) accounts for nearly 30% of TB cases in HIV endemic settings, such as South Africa. The diagnosis of extrapulmonary TB is complicated by the poor performance of Gene Xpert and TB Culture in extrapulmonary fluid (30-50% sensitive), as well as the poor specificity of ADA. We can therefore not reliably use these tests to diagnose EPTB as effectively as we use them in sputum samples. The current best practice for diagnosing pleural TB is to perform a pleural biopsy, which is both invasive and costly. A rapid, easy to use test is needed to allow accurate and fast diagnosis of EPTB. Interferon-gamma is released at high concentrations in extrapulmonary fluid in active EPTB. Antrum Biotech has developed the IRISA-TB assay (validated and SAHPRA licenced) for the diagnosis of EPTB. The study will assess the real-world performance of IRISA-TB compared to ADA, Gene Xpert, and TB Culture when used to diagnose EPTB. We will evaluate IRISA-TB's performance in the following patient groups: * Suspected TB pleural effusion (n= 650) * Suspected TB pericardial effusion (n= 280) * Suspected TB peritonitis (n= 200) * Suspected TB meningitis (n = 1040) As part of our evaluation, we will ask clinicians who treat these patients to provide their feedback on IRISA-TB. We will ask them to indicate to what extent the IRISA-TB test helped them to make treatment decisions. Finally, we will conduct an economic assessment to determine the true cost of diagnosing and treating EPTB to the health system and patients, and we will determine how IRISA-TB could potentially result in cost savings.

Conditions

• Tuberculosis, Extrapulmonary

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	IRISA-TB	ELISA-based assay that detects interferon-gamma concentrations in extrapulmonary fluid in active TB.

Timeline

• Start date: 2021-03-16
• Primary completion: 2025-05-31
• Completion: 2026-05-31
• First posted: 2023-11-18
• Last updated: 2023-11-18

Locations

4 sites across 3 countries: South Africa, Zambia, Zimbabwe