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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
South Africa
University of Cape Town Lung Institute
RECRUITING
Cape Town
University of KwaZulu-Natal
NOT_YET_RECRUITING
Durban
Zambia
Zambart
NOT_YET_RECRUITING
Lusaka
Zimbabwe
Biomedical Research and Training Institute
NOT_YET_RECRUITING
Harare
Contact Information
Primary
Louié E Kühn, MBChB
louie.kuhn@uct.ac.za
+27216505981
Backup
Aliasgar Esmail, MD FCP
ali.esmail@uct.ac.za
+27214066119
Time Frame
Start Date: 2021-03-16
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 2160
Treatments
Experimental: Patients with suspected extrapulmonary tuberculosis
Patients with pleural, pericardial, or peritoneal effusions due to suspected extrapulmonary tuberculosis and those with suspected TB meningitis.
Sponsors
Collaborators: European Union, Biomedical Research and Training Institute, Zambart, University of Cape Town Lung Institute, Leiden University Medical Center
Leads: University of Cape Town

This content was sourced from clinicaltrials.gov

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