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

U

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

248 participants in 2 patient groups

WGS DST strategy
Experimental group
Description:
WGS DST strategy for diagnosing the TB drug resistance profile and an individualised RR-TB treatment recommendation
Treatment:
Device: WGS DST strategy
Standard of Care
No Intervention group
Description:
Standard of care diagnosis of the drug resistance profile and individualised treatment

Trial contacts and locations

0

Loading...

Central trial contact

Annelies Van Rie, PhD, MD; Elise De Vos, MSc

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems