Evaluating Newly Approved Drugs for Multidrug-resistant TB

Summary

endTB Clinical Trial a Phase III, randomized, controlled, open-label, non-inferiority, multi-country trial evaluating the efficacy and safety of five new, all-oral, shortened regimens for multidrug-resistant tuberculosis (MDR-TB).

Conditions

• Tuberculosis, Multidrug-Resistant
• Infection, Bacterial
• Pulmonary Tuberculoses

Interventions

DRUG

Bedaquiline

DRUG

Delamanid

DRUG

Clofazimine

DRUG

Levofloxacin

DRUG

Moxifloxacin

DRUG

Linezolid

DRUG

Pyrazinamide

DRUG

Control arm MDR-TB regimen, consistent with WHO guidelines

Control arm MDR-TB regimen, consistent WHO guidelines

Sponsors & Collaborators

• Partners in Health

  collaborator OTHER

• Harvard Medical School (HMS and HSDM)

  collaborator OTHER

• Epicentre

  collaborator OTHER

• Institute of Tropical Medicine, Belgium

  collaborator OTHER

• Socios En Salud, Peru

  collaborator UNKNOWN

• Interactive Research and Development

  collaborator OTHER

• Médecins Sans Frontières, France

  lead OTHER

Principal Investigators

• Lorenzo Guglielmetti, MD · Médecins Sans Frontières, France

• Carole Mitnick, Sc.D · Harvard Medical School (HMS and HSDM)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-12-31

Primary Completion

2023-06-30

Completion

2023-06-30

Countries

• Georgia
• India
• Kazakhstan
• Lesotho
• Pakistan
• Peru
• South Africa

Study Locations