UnknownNot Applicable

Sequencing Mycobacteria and Algorithm-determined Resistant Tuberculosis Treatment Trial

South Africa248 participantsStarted 2021-09-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

The Effectiveness of a WGS DST strategy for individualisation of RR-TB treatment

Timeframe: Day 0 to month 6 (6 months)

Trial details

NCT IDNCT05017324

SponsorUniversiteit Antwerpen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12

Contact for this trial

Elise De Vos, MSc

0032477715350 elise.devos@uantwerpen.be

View on ClinicalTrials.gov More Rifampicin Resistant Tuberculosis trials