Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q)

Summary

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

Conditions

• Tuberculosis, Multidrug-Resistant
• Tuberculosis
• Pulmonary Tuberculoses
• Mycobacterial Infections
• Bacterial Infections
• Gram-Positive Bacterial Infections

Interventions

DRUG

Bedaquiline 100 MG

Bedaquiline: 400 mg QD x 2 weeks, followed by 200 mg 3x/week

DRUG

Delamanid 50 MG Oral Tablet

Delamanid: 100 mg BID

DRUG

Clofazimine 100 MG Oral Capsule

Clofazimine: 100 mg QD

DRUG

Linezolid 600Mg Tab

Linezolid: 600 mg QD up to Week 16, followed by 300 mg QD or 600 mg 3x/week according to a secondary randomization

DRUG

Control arm MDR-TB regimen, designed according to latest WHO guidelines

Control arm MDR-TB regimen, designed according to latest WHO guidelines (might include bedaquiline, delamanid, linezolid, clofazimine, or all of these drugs).

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

• University of San Francisco

  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

2020-04-06

Primary Completion

2024-10-04

Completion

2024-12-31

Countries

• India
• Kazakhstan
• Lesotho
• Pakistan
• Peru
• Vietnam

Study Locations