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

Status: Active_not_recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years of age or older

• Informed Consent Form signed

• Unwell, suspected to have TB or pneumonia

Locations
Other Locations
Ethiopia
Amhara region
Bahir Dar
South Africa
Stellenbosch University Clinics
Cape Town
United Republic of Tanzania
Kilimanjaro region, Tanzania
Moshi
Time Frame
Start Date: 2021-09-21
Completion Date: 2025-12-31
Participants
Target number of participants: 9097
Treatments
Experimental: SeroSelectTB
The participants in this arm, after providing informed concent, will be tested using the SeroSelectTB rapid assay.
No_intervention: Standard of Care
The participants in this arm, after providing informed consent, will receive the established standard of care.
Related Therapeutic Areas
Sponsors
Collaborators: InVivo BioTech Services GmbH, KNCV Tuberculosis Foundation, Lateral Flow Laboratories (Pty) Ltd, E-MEDDIA, Armauer Hansen Research Institute, Ethiopia, University of Stellenbosch, Kilimanjaro Christian Medical University College, European and Developing Countries Clinical Trials Partnership (EDCTP), Aether Dynamics Consulting & Trading GmbH
Leads: Norwegian Institute of Public Health

This content was sourced from clinicaltrials.gov