MedTrace Logo

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

NCT06135818 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2160

Last updated 2023-11-18

No results posted yet for this study

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

DIAGNOSTIC_TEST

IRISA-TB

ELISA-based assay that detects interferon-gamma concentrations in extrapulmonary fluid in active TB.

Sponsors & Collaborators

  • European Union

    collaborator OTHER

  • Zambart

    collaborator OTHER

  • Biomedical Research and Training Institute

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • University of Cape Town Lung Institute

    collaborator OTHER

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Aliasgar Esmail, MD FCP · UCT Lung Institute, Centre for lung infection and immunity

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-16
Primary Completion
2025-05-31
Completion
2026-05-31

Countries

  • South Africa
  • Zambia
  • Zimbabwe

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06135818 on ClinicalTrials.gov