NCT02342886

Shortening Treatment by Advancing Novel Drugs

A Phase 3 Open-Label Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of the Combination of Moxifloxacin Plus PA-824 Plus Pyrazinamide After 4 and 6 Months of Treatment in Adult Subjects With Drug-Sensitive Smear-Positive Pulmonary Tuberculosis and After 6 Months of Treatment in Adult Subjects With Multi-Drug Resistant, Smear-Positive Pulmonary Tuberculosis.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: Global Alliance for TB Drug Development · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy, safety and tolerability of a combination of moxifloxacin, PA-824, and pyrazinamide treatments with varying doses and treatment lengths from 4 to 6 months in subjects with drug-sensitive (DS) pulmonary TB compared to standard HRZE treatment. This study will also assess the efficacy, safety and tolerability of a combination of moxifloxacin, PA-824, and pyrazinamide treatments after 6 months of treatment in subjects with multi drug-resistant (MDR) pulmonary TB compared to a combination of moxifloxacin, PA-824, and pyrazinamide treatments in DS-TB subjects.

Conditions

• Tuberculosis, Pulmonary, Drug Sensitive
• Tuberculosis, Pulmonary, Multi Drug-resistant

Interventions

Type	Name	Description
DRUG	Moxifloxacin	Oral
DRUG	PA-824	Oral
DRUG	Pyrazinamide	Oral
DRUG	HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)	Oral
DRUG	HR (rifampicin plus isoniazid combination tablets)	Oral

Timeline

• Start date: 2015-02-01
• Primary completion: 2018-01-01
• Completion: 2018-05-01
• First posted: 2015-01-21
• Last updated: 2019-03-26
• Results posted: 2019-03-26

Locations

26 sites across 8 countries: Georgia, Kenya, Malaysia, Philippines, South Africa, Tanzania, Uganda, Zambia