Clinical trial NCT06135818: Same Day Diagnosis of Extrapulmonary TB (TB Serositis and TB Meningitis).
Official title: Same Day Diagnosis of Extrapulmonary TB (TB Serositis and TB Meningitis).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tuberculosis, Extrapulmonary
Keywords: Tuberculosis
Interferon-gamma
Tuberculosis diagnostics
Lead sponsor: University of Cape Town
Sponsor class: OTHER
Collaborators: name: European Union
name: Zambart
name: Biomedical Research and Training Institute
name: Leiden University Medical Center
name: University of Cape Town Lung Institute
First posted: 2023-11-18
Enrollment: 2160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Test-specific performance outcomes
timeFrame: 24 months
Secondary outcomes:
measure: Empiric treatment rates for extrapulmonary TB
timeFrame: 24 months
measure: Cost effectiveness
timeFrame: 24 months.
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: University of KwaZulu-Natal
state: KwaZulu-Natal
city: Cape Town
country: South Africa
facility: University of Cape Town Lung Institute
state: Western Cape
city: Lusaka
country: Zambia
facility: Zambart
city: Harare
country: Zimbabwe
facility: Biomedical Research and Training Institute
Study officials:
affiliation: UCT Lung Institute, Centre for lung infection and immunity
name: Aliasgar Esmail, MD FCP
role: PRINCIPAL_INVESTIGATOR
References: