Clinical Trials Directory

Trials / Unknown

UnknownNCT05017324

Sequencing Mycobacteria and Algorithm-determined Resistant Tuberculosis Treatment Trial

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
248 (estimated)
Sponsor
Universiteit Antwerpen · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

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

Timeline

Start date
2021-09-21
Primary completion
2022-12-01
Completion
2025-01-01
First posted
2021-08-23
Last updated
2021-10-15

Locations

1 site across 1 country: South Africa

Source: ClinicalTrials.gov record NCT05017324. Inclusion in this directory is not an endorsement.