Efficacy and Tolerability of Delamanid, Linezolid, Pyrazinamide and Levofloxacin

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

August 31, 2017

Primary Completion Date

August 31, 2021

Study Completion Date

August 31, 2022

Conditions
Tuberculosis Multi Drug Resistant Active
Interventions
DRUG

Delamanid

Delamanid is a medication used to treat tuberculosis. Specifically it is used, along with other antituberculosis medications, for active multidrug-resistant tuberculosis. It is taken by mouth.

DRUG

Linezolid

Linezolid is an antibiotic used for the treatment of infections caused by Gram-positive bacteria that are resistant to other antibiotics.

DRUG

Levofloxacin

Levoflaxacin is an antibiotic used to treat a number of bacterial infections including acute bacterial sinusitis, pneumonia, urinary tract infections, chronic prostatitis, and some types of gastroenteritis. Along with other antibiotics it may be used to treat tuberculosis.

DRUG

Pyrazinamide

Pyrazinamide is a medication used in combination with other drugs such as isoniazid and rifampicin in the treatment of Mycobacterium tuberculosis.

DRUG

WHO MDR-TB regimen

The WHO guidelines recommend the following 5-agent treatment regimen for MDR-TB: pyrazinamide; a fluoroquinolone; a parenteral agent (typically amikacin or kanamycin); ethionamide (or prothionamide); and either cycloserine or para-aminosalicylic acid, with preference for cycloserine. Short (9 mos) or longer (20-24 mos) treatment schedules can be used.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Westat

OTHER

collaborator

University of Florida

OTHER

lead

Boston University

OTHER