Ignite Creation Date:
2024-05-06 @ 3:41 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02342886
Status:
COMPLETED
Last Update Posted:
2019-03-26
First Post:
2014-10-14
Brief Title:
Shortening Treatment by Advancing Novel Drugs
Sponsor:
Global Alliance for TB Drug Development
Organization:
Global Alliance for TB Drug Development
Study Overview
Official Title:
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
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAND
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None