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 (STAND Trial).
The STAND trial, sponsored by the Global Alliance for TB Drug Development (TB Alliance) is a multi-center and multi-country study with over 50 study sites across Africa, Asia, Eastern Europe and Latin America. The trial is on the new three-drug regimen PaMZ for both TB and MDR-TB patients. In Tanzania the study is done in four sites: IHI (PI, Dr. Francis Mhimbira), Mbeya Medical Research Center-NIMR (PI, Dr. Issa Sabi), Kilimanjaro Clinical Research Institute (KCRI)-Moshi (Prof. Blandina Mmbaga) and NIMR-Mwanza (PI, Dr. George Praygod). The STAND trial is expected to run for 4 years. It is a Phase 3 Open‐Label Partially Randomized Trial.