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

Tuberculosis, Extrapulmonary Clinical Trial

— Epi-TB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06135818
• Other study ID #: Epi-TB
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2021
• Est. completion date: May 31, 2026

Study information

• Verified date: November 2023
• Source: University of Cape Town
• Contact: Louié E Kühn, MBChB
• Phone: +27216505981
• Email: louie.kuhn[@]uct.ac.za
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2160
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Meningitis
• Tuberculosis
• Tuberculosis, Extrapulmonary
• Tuberculosis, Meningeal

Intervention

Diagnostic Test:
• IRISA-TB
ELISA-based assay that detects interferon-gamma concentrations in extrapulmonary fluid in active TB.

Locations

Country	Name	City	State
South Africa	University of Cape Town Lung Institute	Cape Town	Western Cape
South Africa	University of KwaZulu-Natal	Durban	KwaZulu-Natal
Zambia	Zambart	Lusaka
Zimbabwe	Biomedical Research and Training Institute	Harare

Sponsors (6)

Lead Sponsor	Collaborator
University of Cape Town	Biomedical Research and Training Institute, European Union, Leiden University Medical Center, University of Cape Town Lung Institute, Zambart

Countries where clinical trial is conducted

South Africa,  Zambia,  Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Empiric treatment rates for extrapulmonary TB	Clinicians will be asked to indicate whether IRISA-TB made an impact on treatment decisions. Empiric treatment rates for extrapulmonary TB are high due to poor performance of current diagnostics.	24 months
Secondary	Cost effectiveness	Determining the true cost to the health system of various diagnostic strategies.	24 months.