Sequencing Mycobacteria and Algorithm-determined Resistant Tuberculosis Treatment Trial

Phase

N/A

Condition

Lung Disease

Hiv

Treatment

N/A

Clinical Study ID

NCT05017324

AUR1-11-248

T001018N

2020-004084-10

Ages > 18
All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Diagnosed with RR-TB
Diagnosed with pulmonary TB (PTB) or PTB plus extra-pulmonary TB (EPTB)
≥18 years of age
Able to sign informed consent
Not on TB treatment at time of enrolment

Exclusion

Exclusion Criteria:

Patients diagnosed EPTB without pulmonary involvement
Patients with TB Meningitis or TB of the bone.
Has any condition that, in the opinion of the investigator or physician, wouldpreclude provision of informed consent, make participation in the study unsafe,complicate interpretation of study outcome data, interfere with achieving the studyobjectives or compromise patient safety.

Study Design

September 21, 2021

January 31, 2025

Study Description

The trial will be a single blinded randomised controlled, pragmatic, medical device trial evaluating a Whole Genome Sequencing (WGS) Drug Sensitivity Testing (DST) strategy to guide individualised treatment of rifampicin resistant tuberculosis (RR-TB) patients. A total of 248 patients diagnosed with RR-TB in the South African Free State province will by randomised to one of two trial arms. 124 patients will be assigned to the intervention arm, consisting of a WGS DST strategy for diagnosing drug resistance profile and an algorithm-determined individualised RR-TB treatment recommendation. 124 patients will be assigned to the control arm where the diagnosis of Mtb drug resistance and individualisation of RR-TB treatment will happen according to the Standard of Care (SOC) procedures.

Connect with a study center

Free State Department of Health Clinics
Bloemfontein, Free State
South Africa
Active - Recruiting

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