CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 402 enrolled
Drug / intervention
Bedaquiline Oral Tablet +10 moredrug
Likely dose
Bedaquiline Oral Tablet 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04062201
NCT04062201Phase 3Completed
CompareCT.gov

An Open Label, Randomized Controlled Trial to Establish 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 Tuberculosis (RR-TB)

Wits Health Consortium (Pty) Ltd·interventional·Posted Aug 20, 2019·Updated Aug 28, 2024

In Brief

A Phase 3 clinical trial evaluating Bedaquiline Oral Tablet, Linezolid Oral Tablet, and 6 other interventions for Tuberculosis and 4 related conditions. Completed, enrolled 402 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis, Pre-XDR-TB, Extensively Drug-Resistant Tuberculosis, Multi Drug Resistant Tuberculosis, Rifampicin Resistant Tuberculosis
CountriesSouth Africa
CollaboratorsRegents of the University of California, University of Cape Town, Perinatal HIV Research Unit of the University of the Witswatersrand

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedAug 20, 2019
Enrollment StartAug 22, 2019
Primary CompletionApr 15, 2024
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 6.9 years ago

Interventions

Bedaquiline Oral Tabletdrug

Weight Group 16 - 29.9kg: 200mg daily for two weeks; followed by 100mg three times weekly for weeks 3 - 24 Weight Group: 30 - \>50kg: 400mg once daily for 14 days followed by 200mg three times weekly for weeks 3 - 24

Linezolid Oral Tabletdrug

Weight Group 16 - 23kg: 180 - 210mg (crush 1 tab and mix in 10ml water, administer 3-3.5ml. Discard rest) Weight Group 23.1 - 29.9kg: 300mg daily Weight Group 30 - 33.9kg: 450mg daily Weight Group 34 - \>50kg: 600mg daily

Delamanid in Oral Dosage Formdrug

Weight Group 16 - 23kg: 25mg twice daily for 24 weeks Weight Group 23.1 - 33.9kg: 50mg twice daily for 24 weeks Weight Group 34 - \>50kg: 100mg twice daily for 8 weeks followed by 200 mg daily for 16 weeks

Clofazimine Oral Productdrug

Weight Group 16 - 23kg: 100mg three times a week or 50mg daily Weight Group 23.1 - \>50kg: 100mg daily

Levofloxacin Oral Tabletdrug

Weight Group 16 - 23kg: 375 - 500mg daily Weight Group 23.1 - 33.9kg: 500mg once daily Weight Group 34 - 50kg: 750mg daily Weight Group \>50kg:1000mg daily

Isoniazid Oral Productdrug

Weight Group 16 - 23kg: 300mg daily Weight Group 23.1 - 50kg: 400mg daily Weight Group \>50kg: 600mg daily

Ethambutol Oral Productdrug

Weight Group 16 - 23kg: 400mg daily Weight Group 23.1 - 29.9kg: 600mg daily Weight Group 30 - 50kg: 800mg daily Weight Group \>50kg: 1200mg daily

Pyrazinamide Oral Productdrug

Weight Group 16 - 23kg: 750mg daily Weight Group 23.1 - 29.9kg: 1000mg daily Weight Group 30 - 33.9kg: 1250mg daily Weight Group 34 - 50kg: 1500mg daily Weight Group \>50kg: 2000mg daily

Linezolid Oral Tabletdrug

Weight Group 16 - 23kg: 180 - 210mg (crush 1 tab and mix in 10ml water, administer 3-3.5ml. Discard rest) Weight Group 23.1 - 29.9kg: 300mg daily Weight Group 30 - 33.9kg: 450mg daily Weight Group 34 - \>50kg: 600mg daily

Clofazimine Oral Productdrug

Weight Group 16 - 23kg: 100mg three times a week or 50mg daily Weight Group 23.1 - \>50kg: 100mg daily

Levofloxacin Oral Tabletdrug

Weight Group 16 - 23kg: 375 - 500mg daily Weight Group 23.1 - 33.9kg: 500mg once daily Weight Group 34 - 50kg: 750mg daily Weight Group \>50kg:1000mg daily