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Sequencing Mycobacteria and Algorithm-determined Resistant Tuberculosis Treatment Trial

NCT05017324 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2021-10-15

No results posted yet for this study

Summary

The primary aim of this pragmatic trial is to determine the effectiveness of a Whole Genome Sequencing (WGS) Drug Sensitivity Testing (DST) strategy to guide individualised treatment of rifampicin resistant tuberculosis (RR-TB) patients.

The primary objective is to determine the effectiveness of this WGS DST strategy in patients diagnosed with RR-TB. We will additionally perform an exploratory health economics evaluation of both arms, and will determine the feasibility of the WGS DST strategy.

Conditions

  • Rifampicin Resistant Tuberculosis
  • Drug-resistant Tuberculosis
  • Multidrug Resistant Tuberculosis
  • Pulmonary Tuberculoses

Interventions

DEVICE

WGS DST strategy

WGS DST strategy for diagnosing the TB drug resistance profile and an algorithm-determined individualised RR-TB treatment recommendation

Sponsors & Collaborators

  • Aurum Institute

    collaborator OTHER

  • University of Stellenbosch

    collaborator OTHER

  • University of the Free State

    collaborator UNKNOWN

  • Free State Department of Health

    collaborator UNKNOWN

  • Universiteit Antwerpen

    lead OTHER

Principal Investigators

  • Gavin Churchyard, PhD, MD · Aurum Institute

  • Annelies Van Rie, PhD, MD · Universiteit Antwerpen

  • Rob M Warren, PhD · Stellenbosch University, MRC

  • Salome Charalambous, PhD · Aurum Institute

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-21
Primary Completion
2022-12-31
Completion
2025-01-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05017324 on ClinicalTrials.gov