drugset / Trial / NCT02193776

A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis.

NCT02193776 ↗

Phase 2 Completed 240 enrolled Global Alliance for TB Drug Development

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the mycobactericidal activity of combinations of bedaquiline (J), moxifloxacin (M), PA-824 (Pa) and pyrazinamide (Z) regimens during 8 weeks of treatment.

Timeline

Start: 2014-10-23
Primary completion: 2016-02-08
Completion: 2018-02-07

Publications

Tweed CD, Dawson R, Burger DA, Conradie A, Crook AM, Mendel CM, Conradie F, Diacon AH, Ntinginya NE, Everitt DE, Haraka F, Li M, van Niekerk CH, Okwera A, Rassool MS, Reither K, Sebe MA, Staples S, Variava E, Spigelman M. Bedaquiline, moxifloxacin, pretomanid, and pyrazinamide during the first 8 weeks of treatment of patients with drug-susceptible or drug-resistant pulmonary tuberculosis: a multicentre, open-label, partially randomised, phase 2b trial. Lancet Respir Med. 2019 Dec;7(12):1048-1058. doi: 10.1016/S2213-2600(19)30366-2. Epub 2019 Nov 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bedaquiline	Small molecule	200 mg	Oral
Comparator	Ethambutol	Small molecule	550 mg	Oral
Comparator	Ethambutol	Small molecule	825 mg	Oral
Comparator	Ethambutol	Small molecule	1100 mg	Oral
Comparator	Ethambutol	Small molecule	1375 mg	Oral
Comparator	Isoniazid	Small molecule	150 mg	Oral
Comparator	Isoniazid	Small molecule	225 mg	Oral
Comparator	Isoniazid	Small molecule	300 mg	Oral
Comparator	Isoniazid	Small molecule	375 mg	Oral
Subject	Moxifloxacin	Small molecule	400 mg	Oral
Subject	Pretomanid	Small molecule	200 mg	Oral
Subject	Pyrazinamide	Small molecule	800 mg	Oral
Subject	Pyrazinamide	Small molecule	1200 mg	Oral
Subject	Pyrazinamide	Small molecule	1500 mg	Oral
Subject	Pyrazinamide	Small molecule	1600 mg	Oral
Subject	Pyrazinamide	Small molecule	2000 mg	Oral
Comparator	Rifampin	Small molecule	300 mg	Oral
Comparator	Rifampin	Small molecule	450 mg	Oral
Comparator	Rifampin	Small molecule	600 mg	Oral
Comparator	Rifampin	Small molecule	750 mg	Oral

A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis.

Summary

Timeline

Publications

Drugs

Indications