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

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.

Conditions

• Tuberculosis
• Pre-XDR-TB
• Extensively Drug-Resistant Tuberculosis
• Multi Drug Resistant Tuberculosis
• Rifampicin Resistant Tuberculosis

Interventions

DRUG

Bedaquiline Oral Tablet

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

DRUG

Linezolid Oral Tablet

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

DRUG

Delamanid in Oral Dosage Form

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

DRUG

Clofazimine Oral Product

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

DRUG

Levofloxacin Oral Tablet

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

DRUG

Isoniazid Oral Product

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

DRUG

Ethambutol Oral Product

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

DRUG

Pyrazinamide Oral Product

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

DRUG

Linezolid Oral Tablet

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

DRUG

Clofazimine Oral Product

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

DRUG

Levofloxacin Oral Tablet

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

Sponsors & Collaborators

• Regents of the University of California

  collaborator OTHER

• University of Cape Town

  collaborator OTHER

• Perinatal HIV Research Unit of the University of the Witswatersrand

  collaborator OTHER

• Wits Health Consortium (Pty) Ltd

  lead OTHER

Principal Investigators

• Francesca M Conradie · Clinical HIV Research Unit t/a Wits Health Consortium

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-22

Primary Completion

2024-04-15

Completion

2024-04-15

Countries

• South Africa

Study Locations