| Protocol No: | ECCT/14/08/03 | Date of Protocol: | 14-04-2014 |
| Study Title: | Long Title: A Phase 3 Open Label Partially Randomised 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
Short Title: STAND Study (Shortening Treatment by Advancing Novel Drugs) |
| Study Objectives: | |
| Laymans Summary: | |
| Abstract of Study: | The STOP TB (Tuberculosis) partnership aims to halt and reverse the TB epidemic by 2015 through among other strategies, development of new drugs. Current Anti TB medication is taken for six months and is associated with poor adherence and emergence of drug resistant strains. Drug Resistant TB has higher case fatality rates due to the lack of efficacious medications. Shorter, novel regimens are required to address these challenges to achieve TB control goals. This phase III non inferiority trial aims to compare the safety, tolerability and efficacy of a three drug regimen of Pyrazinamide(1500mg daily), Moxifloxacin (400mg daily) and an investigational medication named PA-824 (100mg and 200mg daily) [MPaZ] for treatment of DS and Drug Resistant TB. A total of 1200 DS TB patients will be randomized to receive (100mg of PA-824) in MPaZ for four months,(200mg of PA-824) in MPaZ for four months, (200mg of PA-824) in MPaZ for six months vs RHZE (Standard TB Treatment). An additional 300 patients with Multi Drug Resistant (MDR) TB on MPaZ for six months will be enrolled. Thereafter, follow up will occur for 24 months. |