An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis

Summary

This study aims to evaluate the impact of a new injection-free six-to-nine month treatment regimen of linezolid, bedaquiline, levofloxacin, pyrazinamide (PZA) and ethionamide/high dose isoniazid (INH) compared to the conventional empiric injection-based regimen. The secondary aim is to determine if other treatment-related outcomes including adverse events, adherence to treatment, culture conversion, and cure/completion are significantly different in the intervention and conventional arms.

Conditions

• Tuberculosis
• Multidrug Resistant Tuberculosis
• Extensively-drug Resistant Tuberculosis

Interventions

DRUG

Linezolid

600mg Linezolid po daily, reduced to 300mg po daily if toxicity occurs.

DRUG

Bedaquiline

400mg po daily for 2 weeks, followed by 200mg three times per week .

DRUG

Levofloxacin

750mg (\<50kg) 1000mg (\>50kg)

DRUG

Pyrazinamide

1000-1750mg (40-50kg) 1750-2000mg (51-70kg) 2000-2500mg (71-90kg)

DRUG

Isoniazid

high dose Isoniazid 500mg (40-50kg) 750mg (51-70kg) 750-1000mg (71-90kg)

DRUG

Ethionamide

15mg/kg (max 900mg)

DRUG

Terizidone

750mg (40-70kg) 750-1000mg (71-90kg)

DRUG

Moxifloxacin

400mg po daily.

DRUG

Kanamycin

500-750mg (40-50kg) 1000mg (51-90kg) intramuscular daily during 6-8 month intensive phase.

Sponsors & Collaborators

• University of Limpopo

  collaborator OTHER

• Walter Sisulu University

  collaborator OTHER

• University of Stellenbosch

  collaborator OTHER

• University of Cape Town Lung Institute

  collaborator OTHER

• University of Cape Town

  lead OTHER

Principal Investigators

• Keertan Dheda, MBChB · UCT Lung Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-11-12

Primary Completion

2020-12-31

Completion

2021-08-30

Countries

• South Africa

Study Locations