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| Name | Class |
|---|---|
| European Union | OTHER |
| Zambart | OTHER |
| Biomedical Research and Training Institute | OTHER |
| Leiden University Medical Center |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with suspected extrapulmonary tuberculosis | Experimental | Patients with pleural, pericardial, or peritoneal effusions due to suspected extrapulmonary tuberculosis and those with suspected TB meningitis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRISA-TB | Diagnostic Test | ELISA-based assay that detects interferon-gamma concentrations in extrapulmonary fluid in active TB. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cost effectiveness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Louié E Kühn, MBChB | Contact | +27216505981 | louie.kuhn@uct.ac.za | |
| Aliasgar Esmail, MD FCP | Contact | +27214066119 | ali.esmail@uct.ac.za |
| Name | Affiliation | Role |
|---|---|---|
| Aliasgar Esmail, MD FCP | UCT Lung Institute, Centre for lung infection and immunity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of KwaZulu-Natal | Not yet recruiting | Durban | KwaZulu-Natal | South Africa |
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| ID | Term |
|---|---|
| D000092225 | Tuberculosis, Extrapulmonary |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| OTHER |
| University of Cape Town Lung Institute | OTHER |
Prospective cohort
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Determining the true cost to the health system of various diagnostic strategies. |
| 24 months. |
| University of Cape Town Lung Institute | Recruiting | Cape Town | Western Cape | South Africa |
|
| Zambart | Not yet recruiting | Lusaka | Zambia |
|
| Biomedical Research and Training Institute | Not yet recruiting | Harare | Zimbabwe |
|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |