Triage Test for All Oral DR-TB Regimen (TRiAD Study)

Summary

A Phase 4 operational study to assess the effectiveness, feasibility, acceptability, and cost effectiveness of the GeneXpert MTB/XDR (Xpert XDR; Cepheid) assay for rapid triage-and-treatment of DR-TB-A multi-centre, multi-country prospective cohort study

Conditions

• Drug Resistant Tuberculosis
• MDR-TB
• XDR-TB
• Tuberculosis

Interventions

DIAGNOSTIC_TEST

Xpert® MTB/XDR

The Xpert MTB/XDR Assay, performed on the GeneXpert Instrument Systems, is a nested real-time polymerase chain reaction(PCR) in vitro diagnostic test for the detection of extensively drug resistant (XDR) Mycobacterium tuberculosis (MTB) complex DNA in unprocessed sputum samples or concentrated sediments prepared from sputum. In specimens where MTB is detected, the Xpert MTB/XDR Assay can also detect isoniazid (INH) resistance associated mutations in the katG and fabG1 genes, oxyRahpC intergenic region and inhA promoter; ethionamide (ETH) resistance associated with inhA promoter mutations only; fluoroquinolone (FLQ) resistance associated mutations in the gyrA and gyrB quinolone resistance determining regions (QRDR); and second line injectable drug (SLID) associated mutations in the rrs gene and the eis promoter region.

Sponsors & Collaborators

• KNCV Tuberculosis Foundation

  collaborator OTHER

• Amsterdam Institute for Global Health and Development

  collaborator OTHER

• Ospedale San Raffaele

  collaborator OTHER

• Foundation for Innovative New Diagnostics, Switzerland

  collaborator OTHER

• National Institute for Medical Research, Tanzania

  collaborator OTHER_GOV

• University of St Andrews

  collaborator OTHER

• Global Alliance for TB Drug Development

  collaborator OTHER

• Wits Health Consortium (Pty) Ltd

  collaborator OTHER

• Institute of Human Virology, Nigeria

  collaborator OTHER

• Ethiopian Public Health Institute

  collaborator OTHER_GOV

• Centre for the AIDS Programme of Research in South Africa

  lead NETWORK

Principal Investigators

• Kogieleum Naidoo, MBCHB, PHD · Deputy Director -CAPRISA

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-26

Primary Completion

2024-12-31

Completion

2025-06-01

Countries

• Ethiopia
• Nigeria
• South Africa

Study Locations