The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB

Summary

Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing. Despite the availability and effectiveness of affordable six-month treatments for tuberculosis (TB), the worldwide control of this disease is currently being impacted by the emergence of multidrug resistant TB (MDR-TB). MDR-TB refers to TB that is resistant to at least isoniazid and rifampicin. These are the two most powerful first-line drugs used to treat pulmonary TB. MDR-TB usually develops while a person is taking TB treatment due to either inappropriate treatment or failure of patients to comply with their treatment. This strain of drug-resistant bacteria can also be spread to other people through the air. With the incident rate of MDR-TB on the rise, there is a need to investigate optimal treatment regimens using effective drugs.

Conditions

• MDR-TB

Interventions

DRUG

Regimen A locally-used WHO-approved MDR-TB regimen (2011 guideline)

Drug: Locally-used WHO-approved MDR-TB regimen

DRUG

Moxifloxacin

Moxifloxacin is an 8-methoxy quinolone, and an anti-bacterial fluoroquinolone

DRUG

Clofazimine

Clofazimine, is an antileprosy and anti-bacterial agent. Its chemical name is 3-(p-chloroanilino)-10-(p-chlorophenyl)-2, 10-dihydro-2-isopropyliminophenazine.

DRUG

Ethambutol

Ethambutol is a bacteriostatic that acts against virtually all strains of Mycobacterium tuberculosis and M. bovis and is also active against other mycobacteria such as M. Kansasii.

DRUG

Pyrazinamide

Pyrazinamide is bactericidal against intracellular mycobacterium tuberculosis. It is a prodrug that is converted into its active form, pyrazinoic acid, by a mycobacterial enzyme, pyrazinamidase, as well as through hepatic metabolism.

DRUG

Isoniazid

Isoniazid is a bactericidal in vitro and in vivo against actively dividing tubercle bacilli. Its primary action is to inhibit the synthesis of long-chain mycolic acids, which are unique constituents of mycobacterial cell wall.

DRUG

Prothionamide

Prothionamide has a bacteriostatic action.

DRUG

Kanamycin

Kanamycin is a bactericidal antibiotic from the group of aminoglycosides.

DRUG

Levofloxacin

Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone class that acts on the DNA-DNA-gyrase complex and topoisomerase IV. It is the S (-) enantiomer of the racemic active substance ofloxacin.

DRUG

Bedaquiline

Bedaquiline is a novel diarylquinoline antibiotic with bactericidal activity

Sponsors & Collaborators

• Medical Research Council

  collaborator OTHER_GOV

• Institute of Tropical Medicine, Belgium

  collaborator OTHER

• Liverpool School of Tropical Medicine

  collaborator OTHER

• Rede TB

  collaborator INDUSTRY

• IUATLD, Inc

  lead OTHER

Principal Investigators

• Sarah Meredith, MD · Medical Research Council

• Andrew Nunn, PhD · Medical Research Council

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-03-31

Primary Completion

2022-05-13

Completion

2023-05-02

Countries

• Ethiopia
• Georgia
• India
• Moldova
• Mongolia
• South Africa
• Uganda

Study Locations