Economic Evaluation of New MDR TB Regimens

Summary

The current treatment regimen for MDR-TB has poor outcomes and costs of treating MDR-TB are greater than treating drug susceptible TB, both in terms of health service and patient-incurred costs. Urgent action is needed to Identify short, effective and tolerable treatments for people with MDR-TB. The PRACTECAL economic evaluation sub-study (PRACTECAL-EE) will take place alongside the TB PRACTECAL trial, aiming to assess the costs to patients and providers of such regimens and to estimate the cost-effectiveness and poverty impact of an introduction of new MDR-TB regimens in the three countries participating in the main study.

Conditions

• Multi-drug Resistant Tuberculosis
• Extensively Drug-Resistant Tuberculosis
• Pulmonary Tuberculoses

Interventions

DRUG

Bedaquiline

Bedaquiline is a diarylquinoline class antimicrobial which blocks the proton pump for ATP synthase of mycobacteria. This in turn blocks the ATP production required for cellular energy production and leading to cell death.

DRUG

Pretomanid

Pretomanid is an nitroimidazole class antimicrobial which interferes with cell wall biosynthesis in mycobacteria. It may have other mechanisms of action as well in non-replicating mycobacteria.

DRUG

Moxifloxacin

Moxifloxacin is an 8-methoxyquinolone class antimicrobial that is a potent inhibitor of DNA gyrase and topoisomerase IV in bacteria

DRUG

Linezolid

Linezolid, an oxazolidinone class antimicrobial which works by inhibiting ribosomal protein synthesis. It is approved for Gram-positive bacterial infections, and is increasingly being used for drug resistant TB disease.

DRUG

Clofazimine

Clofazimine (Cfz) is a lipophilic riminophenazine licensed for treatment of leprosy. Its mechanism(s) of action remains unclear, but existing evidence suggests production of reactive oxygen species within Mycobacterium tuberculosis is one mechanism.

DRUG

Standard Drugs

Locally accepted standard of care which is consistent with the WHO recommendations for the treatment of M/XDR-TB.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• Ministry of Health, Republic of Uzbekistan

  collaborator OTHER_GOV

• Ministry of Public Health, Republic of Belarus

  collaborator OTHER_GOV

• THINK TB & HIV Investigative Network

  collaborator NETWORK

• University of Liverpool

  collaborator OTHER

• Wits Health Consortium (Pty) Ltd

  collaborator OTHER

• Medecins Sans Frontieres, Netherlands

  lead OTHER

Principal Investigators

• Sedona Sweeny · London School of Hygiene and Tropical Medicine

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-20

Primary Completion

2022-08-25

Completion

2022-08-25

Countries

• Belarus
• South Africa
• Uzbekistan

Study Locations