NCT03896685 - Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q) | Biotech Hunter

Enrollment

323

Participants

Timeline

Start Date

April 6, 2020

Primary Completion Date

October 4, 2024

Study Completion Date

December 31, 2024

Conditions

Tuberculosis, Multidrug-ResistantTuberculosisPulmonary TuberculosesMycobacterial InfectionsBacterial InfectionsGram-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).

Trial Locations (10)

1390

Centro de Investigación del Hospital Nacional Hipólito Unanue, Lima

Unknown

Aundh Chest Hospital, Pune

National Center for Tuberculosis Problems, Almaty

"State Municipal Enterprise on the right of economic management City Centre of Phthisiopulmonology of Nur-sultan city's administration", Almaty

Partners In Health Lesostho, Maseru

The Indus Hospital, Karachi

Institute of Chest Disease,, Kotri

Centro de Investigación de Enfermedades Neumológicas del Hospital Nacional Sergio Bernales, Lima

Hanoi Lung Hospital, Hanoi

Pham Ngoc Thach Hospital, Ho Chi Minh City