Evaluating Newly Approved Drugs for Multidrug-resistant TB

PHASE3CompletedINTERVENTIONAL
Enrollment

754

Participants

Timeline

Start Date

December 31, 2016

Primary Completion Date

June 30, 2023

Study Completion Date

June 30, 2023

Conditions
Tuberculosis, Multidrug-ResistantInfection, BacterialPulmonary 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

Trial Locations (12)

1390

Centro de Investigación del Hospital Nacional Hipólito Unanue, Lima

7784

Medecins Sans Frontieres Belgium, Khayelitsha

0101

National Center for Tuberculosis and Lung Diseases, Tbilisi

Unknown

Aundh Chest Hospital, Pune

National Center for Tuberculosis Problems, 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

Hospital Nacional Dos de Mayo Parque Historia de la Medicina, Lima

020000

City Centre of Phthisiopulmonology, Almaty

050030

Center of Phthisiopulmonology of Almaty Health Department, Almaty

All Listed Sponsors
collaborator

Partners in Health

OTHER

collaborator

Harvard Medical School (HMS and HSDM)

OTHER

collaborator

Epicentre

OTHER

collaborator

Institute of Tropical Medicine, Belgium

OTHER

collaborator

Socios En Salud, Peru

UNKNOWN

collaborator

Interactive Research and Development

OTHER

lead

Médecins Sans Frontières, France

OTHER