Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB

PHASE2RecruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

June 7, 2022

Primary Completion Date

May 31, 2027

Study Completion Date

May 31, 2027

Conditions
Tuberculosis, Multidrug-Resistant
Interventions
DRUG

Delamanid

"Frequency: daily Route of administration: oral~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

Levofloxacin

"Frequency: daily Route of administration: oral~Levofloxacin 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

Bedaquiline

"Frequency: daily Route of administration: oral~Bedaquiline is indicated for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability."

DRUG

Clofazimine

"Frequency: daily Route of administration: oral~Clofazimine has shown activity against multidrug-resistant tuberculosis (MDR-TB) and is now recommended by the World Health Organization (WHO) to treat drug resistant tuberculosis as a Group B drug. It is thought that clofazimine acts by inhibiting the formation of matrixes within the DNA and thus delaying the growth of the bacterium. Clofazimine first received FDA approval in 1986, although its use in the treatment of MDR-TB has not been approved by any stringent regulatory authorities and it is therefore used off-label for this function."

DRUG

Linezolid

"Frequency: daily Route of administration: oral~Linezolid is an antibiotic used for the treatment of infections caused by Gram-positive bacteria that are resistant to other antibiotics."

Trial Locations (2)

4114

RECRUITING

De La Salle Health Sciences Institute, Dasmariñas

Unknown

RECRUITING

National Lung Hospital, Hanoi

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

collaborator

Pfizer

INDUSTRY

collaborator

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

collaborator

University of California, San Francisco

OTHER

collaborator

Westat

OTHER

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

University of Colorado, Denver

OTHER

collaborator

Harvard Medical School (HMS and HSDM)

OTHER

collaborator

National Lung Hospital, Vietnam

UNKNOWN

collaborator

De La Salle Health Sciences Institute, Philippines

UNKNOWN

lead

Boston University

OTHER