Sequencing Mycobacteria and Algorithm-determined Resistant Tuberculosis Treatment Trial (SMARTT)

Universiteit Antwerpen

Status

Enrolling

Conditions

Multidrug Resistant Tuberculosis

Drug-resistant Tuberculosis

Pulmonary Tuberculoses

Rifampicin Resistant Tuberculosis

Treatments

Device: WGS DST strategy

Study type

Interventional

Funder types

Other

Identifiers

NCT05017324

AUR1-11-248

T001018N (Other Grant/Funding Number)

2020-004084-10 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

248 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, interfere with achieving the study objectives or compromise patient safety.