Evaluation of a Rapid Point-of-Care Serological Triage Test for Active TB (SeroSelectTB)
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|ClinicalTrials.gov Identifier: NCT04752592|
Recruitment Status : Recruiting
First Posted : February 12, 2021
Last Update Posted : April 3, 2023
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The performance of a new triage test for active tuberculosis (TB), SeroSelectTB, will be qualified in multi-centre randomised controlled trials at health-posts in South Africa, Tanzania and Ethiopia. Cost effectiveness evaluations will be conducted to support a value proposition to stakeholders and regulatory authorities, and to support commercialization requirements.
Consenting adults will provide blood and saliva samples for screening by SeroSelectTB, and sputum collected for routine TB diagnosis by the health services. Clinical and sociodemographic information will be collected.
A reliable rapid test will make it possible to identify and selectively treat those with active TB at the local healthcare level. The expected impact includes accurate same-day diagnosis of patients with active TB, reduction of diagnostic delay and TB transmission, and diagnostic cost-savings for patients and healthcare systems in high TB-burden countries.
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis, Pulmonary||Diagnostic Test: SeroSelectTB rapid TB test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16682 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Feasibility, Accuracy, and Effect of a Rapid Point-of-Care Serological Triage Test for Active TB (SeroSelectTB) in High Burden, HIV-endemic African Settings: a Multi-centre, Parallel-group, Randomised, Controlled Trial|
|Actual Study Start Date :||September 21, 2021|
|Estimated Primary Completion Date :||January 31, 2024|
|Estimated Study Completion Date :||December 31, 2025|
The participants in this arm, after providing informed concent, will be tested using the SeroSelectTB rapid assay.
Diagnostic Test: SeroSelectTB rapid TB test
The SeroSelectTB test is a rapid blood-based immunochemical lateral flow assay for the detection of active tuberculosis.
No Intervention: Standard of Care
The participants in this arm, after providing informed consent, will receive the established standard of care.
- To determine the impact of SeroSelectTB on health systems' diagnostic delay in Ethiopia, Tanzania and South Africa. [ Time Frame: The time points will be measure from the data of SeroSelectTB test or standard-of-care until the start of treatment (when active TB is diagnosed). Participants receiving TB therapy will be followed for 6 months according to national routines. ]
Our hypothesis is that the use of a rapid triage assay at patients' first encounter with the healthcare system will, when compared to the standard-of-care, reduce time to TB diagnosis.
The assessment of the primary objective will be based on two complementary measures: primary measure is time to diagnosis (measured in days), and secondary measure is time to treatment (measured in days).
- To describe SeroSelectTB performance in field conditions, including sensitivity and specificity, and positive and negative predictive values, in the study populations. [ Time Frame: Investigations will be performed during the intervention. ]Test accuracy will be documented through bench-based evaluations at partner institutions in Cape Town and through external quality control investigations at RIVM.
- Evaluate cost-effectiveness of SeroSelectTB. [ Time Frame: Cost effectiveness will be determined at year 4. ]The overall cost of TB diagnosis, treatment and care by 1) implementing a new rapid triage test at peripheral healthcare facilities and 2) standard-of-care at peripheral healthcare facilities will be evaluated.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 18 years of age or older
- Informed Consent Form signed
- Unwell, suspected to have TB or pneumonia
- Currently receiving TB treatment
- On TB treatment past 30 days or more, or last dose less than 1 month before enrolment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04752592
|Contact: Carol Holm-Hansen, PhDemail@example.com|
|Contact: Aida Babaii, MAfirstname.lastname@example.org|
|Bahir Dar, Ethiopia|
|Contact: Kidist Bobosha, PhD email@example.com|
|Contact: Melese Yeshambaw, MPH firstname.lastname@example.org|
|Principal Investigator: Kidist Bobosha, PhD|
|Stellenbosch University Clinics||Recruiting|
|Cape Town, Western Cape, South Africa, 7505|
|Contact: Grant Theron, PhD email@example.com|
|Contact: Anna Okunola, PhD firstname.lastname@example.org|
|Principal Investigator: Grant Theron, PhD|
|Kilimanjaro region, Tanzania||Recruiting|
|Contact: Balthazar Nyombi email@example.com|
|Contact: Hadija Semvua firstname.lastname@example.org|
|Principal Investigator: Balthazar Nyombi, PhD|
|Principal Investigator:||Grant Theron, PhD||University of Stellenbosch|
|Principal Investigator:||Balthazar Nyombi, PhD||Kilimanjaro Christian Medical University College|
|Principal Investigator:||Kidist Bobosha, PhD||Armauer Hansen Research Institute|
|Principal Investigator:||Carol Holm-Hansen, PhD||Norwegian Institute of Public Health|
Study Data/Documents: Study Protocol
|Responsible Party:||Norwegian Institute of Public Health|
|Other Study ID Numbers:||
|First Posted:||February 12, 2021 Key Record Dates|
|Last Update Posted:||April 3, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Only the documents below will be shared. No data with personal identifiers will be shared, all shared data that will be analysed will be anonymized and scrambled.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|Time Frame:||The anonymized data will be available for two years after the date of final publication.|
|Access Criteria:||Interested parties should directly contact the principle investigators to request access and adhere to the institutional and national regulations for data sharing.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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