Status:
RECRUITING
Same Day Diagnosis of Extrapulmonary TB (TB Serositis and TB Meningitis).
Lead Sponsor:
University of Cape Town
Collaborating Sponsors:
European Union
Zambart
Conditions:
Tuberculosis, Extrapulmonary
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
2160 Patients enrolled
Trial Details
Trial ID
NCT06135818
Start Date
March 16 2021
End Date
May 31 2026
Last Update
November 18 2023
Active Locations (4)
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1
University of KwaZulu-Natal
Durban, KwaZulu-Natal, South Africa
2
University of Cape Town Lung Institute
Cape Town, Western Cape, South Africa
3
Zambart
Lusaka, Zambia
4
Biomedical Research and Training Institute
Harare, Zimbabwe