Tuberculosis, ExtrapulmonaryEpi-TBNCT06135818
Same Day Diagnosis of Extrapulmonary TB (TB Serositis and TB Meningitis).
A study testing IRISA-TB in people with Tuberculosis, Extrapulmonary, run by University of Cape Town at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Extrapulmonary
- What is being tested?
- IRISA-TB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,160 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 16 Mar 2021to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
South Africa2 sites, 2 recruiting
- Recruiting
University of Cape Town Lung Institute
Cape Town, Western Cape
Keertan Dheda, MD/PhD, keertan.dheda@uct.ac.za
Ali Esmail, MD, a.esmail@uct.ac.za
- Not yet recruiting
University of KwaZulu-Natal
Durban, KwaZulu-Natal
Kennedy Nyamande, nyamandek@ukzn.ac.za
Zambia1 site, 1 recruiting
- Not yet recruiting
Zambart
Lusaka
Omar Siddiqi, MD, osiddiqi@bidmc.harvard.edu
Kondwelani Mateyo, MD
Zimbabwe1 site, 1 recruiting
- Not yet recruiting
Biomedical Research and Training Institute
Harare
Junior Mutsvangwa, MBChB
About this study
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.
- Conditions
- Tuberculosis, Extrapulmonary
- Being tested
- IRISA-TB
- Keywords
- Tuberculosis, Interferon-gamma, Tuberculosis diagnostics
- Medical subject headings
- Tuberculosis, Extrapulmonary, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRISA-TBDiagnostic test
ELISA-based assay that detects interferon-gamma concentrations in extrapulmonary fluid in active TB.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected extrapulmonary tuberculosis | Experimental | Patients with pleural, pericardial, or peritoneal effusions due to suspected extrapulmonary tuberculosis and those with suspected TB meningitis. Receives: Diagnostic Test: IRISA-TB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 months
Secondary outcomes (2)
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.
Measured: 24 months
Cost effectiveness
Determining the true cost to the health system of various diagnostic strategies.
Measured: 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start16 Mar 2021
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, ExtrapulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort
- Masking
- None (open label)
- Enrolment
- 2,160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, Zambart, Biomedical Research and Training Institute, Leiden University Medical Center, University of Cape Town Lung Institute
- Responsible party
- Sponsor
- Investigators
- Aliasgar Esmail, MD FCP, Principal investigator, UCT Lung Institute, Centre for lung infection and immunity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135818
- Sponsor's protocol ID
- Epi-TB
- Acronym
- Epi-TB
- Status last verified
- Nov 2023
- First submitted
- 13 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Same Day Diagnosis of Extrapulmonary TB (TB Serositis and TB Meningitis).
- ClinicalTrials.gov ID
- NCT06135818
- Acronym / sponsor ID
- Epi-TB / Epi-TB
- Conditions
- Tuberculosis, Extrapulmonary
- Keywords
- Tuberculosis, Interferon-gamma, Tuberculosis diagnostics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,160 participants (estimated)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- European Union, Zambart, Biomedical Research and Training Institute, Leiden University Medical Center, University of Cape Town Lung Institute
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected extrapulmonary tuberculosis | Experimental | Diagnostic Test: IRISA-TBPatients with pleural, pericardial, or peritoneal effusions due to suspected extrapulmonary tuberculosis and those with suspected TB meningitis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRISA-TBELISA-based assay that detects interferon-gamma concentrations in extrapulmonary fluid in active TB. | Diagnostic test | Patients with suspected extrapulmonary tuberculosis |
Primary outcome
Test-specific performance outcomes
Time frame: 24 months
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)
2 secondary outcomes
Empiric treatment rates for extrapulmonary TB
Time frame: 24 months
Cost effectiveness
Time frame: 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aliasgar Esmail, MD FCP principal investigator
UCT Lung Institute, Centre for lung infection and immunity
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRISA-TB in people with Tuberculosis, Extrapulmonary, run by University of Cape Town at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Africa, Zambia, Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louié E Kühn, MBChB (+27216505981, louie.kuhn@uct.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test-specific performance outcomes (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.