Linezolid Dosing Strategies in Drug-Resistant TB

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

138

Participants

Timeline

Start Date

August 11, 2022

Primary Completion Date

March 14, 2025

Study Completion Date

March 13, 2026

Conditions
Tuberculosis, Multidrug-ResistantTuberculosisTuberculosis, 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

Trial Locations (13)

2092

Wits Helen Joseph Hospital CRS (Wits HJH CRS) (Site ID: 11101), Johannesburg

4052

Durban International CRS (Site ID: 11201), Durban

4114

De La Salle Health Science Institute Angelo King Medical Research Center (DLSHSI-AKMRC) (Site ID: 31981), Cavite

7700

University of Cape Town Lung Institute (UCTLI) CRS (Site ID: 31792), Cape Town

7705

South African Tuberculosis Vaccine Initiative (SATVI) CRS (Site ID: 31793), Cape Town

10330

Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site ID: 31802), Pathum Wan

15063

Barranco CRS (Site ID: 11301), Lima

50200

Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS (Site ID: 31784), Chiang Mai

Unknown

Gaborone CRS (Site ID: 12701), Gaborone

21040-360

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS (Site ID: 12101), Rio de Janeiro

HT-6110

GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS (Site ID: 31730), Port-au-Prince

Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS (Site ID: 30022), Port-au-Prince

0300

Rustenburg CRS (Site ID: 31684), Rustenburg

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH