PRACTECAL-PKPD Sub Study

Summary

PRACTECAL-PKPD is an exploratory pharmacokinetic and pharmacodynamic sub-study investigating the relationship between the patients' exposure to anti- tuberculosis (TB) drugs in the TB-PRACTECAL trial investigational regimens and their respective treatment outcomes.

Conditions

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

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.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• Global Alliance for TB Drug Development

  collaborator OTHER

• University College, London

  collaborator OTHER

• Drugs for Neglected Diseases

  collaborator OTHER

• Swiss Tropical & Public Health Institute

  collaborator OTHER

• eResearch Technology, Inc.

  collaborator INDUSTRY

• Ministry of Health, Republic of Uzbekistan

  collaborator OTHER_GOV

• World Health Organization

  collaborator OTHER

• 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

• Hackensack Meridian Health

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Minsk Republican Research and Practical Centre for Pulmonology and Tuberculosis

  collaborator UNKNOWN

• Medecins Sans Frontieres, Netherlands

  lead OTHER

Principal Investigators

• Bern Nyang'wa, MB BS, MPH · Medecins Sans Frontieres, Netherlands

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-06

Primary Completion

2022-09-30

Completion

2022-09-30

Countries

• Belarus
• South Africa

Study Locations