Rapid diagnosis of extrapulmonary tuberculosis
Same Day Diagnosis of Extrapulmonary TB (TB Serositis and TB Meningitis).
This study is testing a new test called IRISA-TB to see if it can quickly and accurately diagnose extrapulmonary tuberculosis in people showing TB symptoms, especially in areas with high HIV rates.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cape Town Academic / other |
| Locations | 4 sites (Durban, KwaZulu-Natal and 3 other locations) |
| Trial ID | NCT06135818 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the IRISA-TB assay for diagnosing extrapulmonary tuberculosis (EPTB) in patients presenting with symptoms of TB. It compares the performance of IRISA-TB against standard diagnostic methods such as ADA, Gene Xpert, and TB Culture. The goal is to provide a faster and more accurate diagnostic tool that can be used in real-world settings, particularly in regions heavily affected by HIV. Participants will provide serosal or cerebrospinal fluid samples for testing.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over who exhibit symptoms of TB and have serosal or CSF fluid samples available for testing.
Not a fit: Patients who do not have symptoms of TB or whose fluid samples are insufficient for testing will not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to quicker and more accurate diagnoses of extrapulmonary TB, improving patient outcomes and treatment initiation.
How similar studies have performed: Other studies have shown promise in developing rapid diagnostic tests for TB, but the specific approach of using the IRISA-TB assay for EPTB is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Durban, KwaZulu-Natal and 3 other locations
- 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)
Study contacts
- Principal investigator: Aliasgar Esmail, MD FCP — UCT Lung Institute, Centre for lung infection and immunity
- Study coordinator: Louié E Kühn, MBChB
- Email: louie.kuhn@uct.ac.za
- Phone: +27216505981
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.