Linezolid Dosing Strategies in Drug-Resistant TB

Summary

The purpose of the study was to evaluate the efficacy (how well the medicines work) and tolerability (whether participants stop treatment because of side effects from a drug) of an anti-TB treatment regimen that compared two doses of linezolid (LZD), combined with bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ). This study also measured the level of LZD and BDQ in the participants' blood.

Conditions

• Tuberculosis, Multidrug-Resistant
• Tuberculosis
• Tuberculosis, Pulmonary

Interventions

DRUG

Linezolid 600 mg

One 600mg tablet taken orally once daily (QD) in the morning during weeks 1-26

DRUG

Linezolid 1200 mg (QD)

Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4

DRUG

Linezolid 1200 mg (TIW)

Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26

DRUG

Bedaquiline 200 mg

Two 100mg tablets taken orally once daily in the morning during weeks 1-8

DRUG

Bedaquiline 100 mg

One 100mg tablet taken orally once daily in the morning during weeks 9-26

DRUG

Delamanid 300 mg

Six 50mg tablets taken orally once daily in the morning during weeks 1-26

DRUG

Clofazimine 300 mg

Three 100mg capsules taken orally once daily in the morning during weeks 1-2

DRUG

Clofazimine 100 mg

One 100mg capsule taken orally once daily in the morning during weeks 3-26

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.

  collaborator INDUSTRY

• Pfizer

  collaborator INDUSTRY

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Constance A. Benson · The University of California, San Diego

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-27

Primary Completion

2025-03-14

Completion

2026-01-13

FDA Drug

Yes

Countries

• Botswana
• Brazil
• Haiti
• Peru
• Philippines
• South Africa
• Thailand

Study Locations