Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Compa… (NCT04062201) | Clinical Trial Compass
CompletedPhase 3
Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of Care
South Africa402 participantsStarted 2019-08-22
Plain-language summary
BEAT Tuberculosis is a phase 3, open label, multi-centre, randomized controlled trial. The purpose of this trial is to compare the efficacy and safety of a Study Strategy consisting of 6 months of bedaquiline (BDQ), delamanid (DLM), and linezolid (LNZ), with levofloxacin (LVX) and clofazimine (CFZ) compared to the current South African Standard of Care (Control Strategy) for 9 months for the treatment of rifampicin resistant (RR-TB) Tuberculosis.
Who can participate
Age range
6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Haemoglobin level of \< 8.0 g/dL
. Platelet count \< 75,000/mm\^3
. Absolute neutrophil count (ANC) \< 1000/ mm\^3
. An estimated creatinine clearance (CrCl) less than 30 mL/min as calculated by the National Health Laboratory Service (NHLS) equation
. Alanine aminotransferase (ALT) ≥3 x upper limit of normal (ULN)
. Total bilirubin grade 3 or greater (\>2.0 x ULN, or \>1.50 x ULN when accompanied by any increase in other liver function test)
. Serum potassium less than 3.2 mmol/l
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proportion of participants with a successful outcome at the end of treatment
Timeframe: From 24 weeks to 76 weeks depending on assigned strategy and type of TB
2
The proportion of participants with a successful outcome at the end of follow up at 76 weeks post treatment initiation
Timeframe: At the end of follow up at 76 weeks post treatment initiation
3
The proportion of participants who experience grade 3 or greater adverse events during treatment and up to 30 days following the end of treatment
Timeframe: From treatment initiation to 30 days following the end of treatment