Evaluation of a Rapid Point-of-Care Serological Triage Test for Active TB

NCT04752592 | Completed DMC

• 1 other identifier: 19/10773
• Study Type: interventional
• Target: 9,097
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Tuberculosis, Pulmonary

Keywords

Tuberculosis; Rapid diagnostics; Triage test; Diagnostic delay; Low-income countries; Africa

Outcome Measures

Primary Outcomes (1)

• To determine the impact of SeroSelectTB on health systems' diagnostic delay in Ethiopia, Tanzania and South Africa.

  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).

  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.

Secondary Outcomes (2)

• To describe SeroSelectTB performance in field conditions, including sensitivity and specificity, and positive and negative predictive values, in the study populations.

  Investigations will be performed during the intervention.

• Evaluate cost-effectiveness of SeroSelectTB.

  Cost effectiveness will be determined at year 6.

Study Arms (2)

SeroSelectTB

EXPERIMENTAL

The participants in this arm, after providing informed concent, will be tested using the SeroSelectTB rapid assay.

Diagnostic Test: SeroSelectTB rapid TB test

Standard of Care

NO INTERVENTION

The participants in this arm, after providing informed consent, will receive the established standard of care.

Interventions

SeroSelectTB rapid TB test DIAGNOSTIC_TEST

The SeroSelectTB test is a rapid blood-based immunochemical lateral flow assay for the detection of active tuberculosis.

SeroSelectTB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Informed Consent Form signed
• Unwell, suspected to have TB or pneumonia

You may not qualify if:

• Currently receiving TB treatment
• On TB treatment past 30 days or more, or last dose less than 1 month before enrolment

Sponsors & Collaborators

• Lateral Flow Laboratories (Pty) Ltd: collaborator
• InVivo BioTech Services GmbH: collaborator
• Aether Dynamics Consulting & Trading GmbH: collaborator
• E-MEDDIA: collaborator
• KNCV Tuberculosis Foundation: collaborator
• Norwegian Institute of Public Health: lead
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator
• University of Stellenbosch: collaborator
• Armauer Hansen Research Institute, Ethiopia: collaborator
• KCMC University, Tanzania: collaborator

Study Sites (3)

Sidama region

Awasa, Ethiopia

Location

Stellenbosch University Clinics

Cape Town, Western Cape, 7505, South Africa

Location

Kilimanjaro region, Tanzania

Moshi, Tanzania

Location

Related Links

• Project website

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Grant Theron, PhD

  University of Stellenbosch

  PRINCIPAL INVESTIGATOR

• Balthazar Nyombi, PhD

  Kilimanjaro Christian Medical Centre, Tanzania

  PRINCIPAL INVESTIGATOR

• Kidist Bobosha, PhD

  ARMAUER HANSEN RESEARCH INSTITUTE

  PRINCIPAL INVESTIGATOR

• Carol Holm-Hansen, PhD

  Norwegian Institute of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 12, 2021
• Study Start: September 21, 2021
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

ZA (1); ET (1); TA (1)