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

NCT06135818 | Recruiting

• 1 other identifier: Epi-TB
• Study Type: interventional
• Target: 2,160
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

Tuberculosis; Interferon-gamma; Tuberculosis diagnostics

Outcome Measures

Primary Outcomes (1)

• Test-specific performance outcomes

  Comparison of sensitivity, specificity, accuracy, predictive values, likelihood ratios, number needed to treat (NNT) and indeterminate rate for the various diagnostic assays (IRISA-TB, ADA, Gene Xpert, TB Culture)

  24 months

Secondary Outcomes (2)

• Empiric treatment rates for extrapulmonary TB

  24 months

• Cost effectiveness

  24 months.

Study Arms (1)

Patients with suspected extrapulmonary tuberculosis

EXPERIMENTAL

Patients with pleural, pericardial, or peritoneal effusions due to suspected extrapulmonary tuberculosis and those with suspected TB meningitis.

Diagnostic Test: IRISA-TB

Interventions

IRISA-TB DIAGNOSTIC_TEST

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

Patients with suspected extrapulmonary tuberculosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants 18 years and over attending health care facility with symptoms of TB.
• Serosal or CSF fluid sample provided to NHLS with sufficient volume to perform SOC tests + 1ml.
• Patients in whom extrapulmonary TB is part of the treating clinicians' differential diagnosis.

You may not qualify if:

• 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)
• Patients with current significant history of substance or alcohol abuse that may impact study visits.
• Patients who are unable to communicate by telephone or who do not have a current active traceable contact number.
• Patients not willing to undergo an HIV test.
• Patients whose fluid sample volumes are insufficient to perform standard of care testing in addition to IRISA-TB
• Positive sputum GXP within 2 weeks prior to serosal fluid or CSF sampling.

Sponsors & Collaborators

• University of Cape Town: lead
• European Union: collaborator
• Zambart: collaborator
• Biomedical Research and Training Institute: collaborator
• Leiden University Medical Center: collaborator
• University of Cape Town Lung Institute: collaborator

Study Sites (4)

University of KwaZulu-Natal

Durban, KwaZulu-Natal, South Africa

NOT YET RECRUITING

University of Cape Town Lung Institute

Cape Town, Western Cape, South Africa

RECRUITING

Zambart

Lusaka, Zambia

NOT YET RECRUITING

Biomedical Research and Training Institute

Harare, Zimbabwe

NOT YET RECRUITING

MeSH Terms

Conditions

Tuberculosis, Extrapulmonary; Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Aliasgar Esmail, MD FCP

  UCT Lung Institute, Centre for lung infection and immunity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louié E Kühn, MBChB

CONTACT

+27216505981; louie.kuhn@uct.ac.za

Aliasgar Esmail, MD FCP

CONTACT

+27214066119; ali.esmail@uct.ac.za

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: March 16, 2021
• Primary Completion: May 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

ZI (1); ZA (1)