Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01168713 | Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia | PHASE2 | COMPLETED | 132 | — | — | Aug 1, 2010 | Jul 1, 2011 | Mar 3, 2017 | 55 | United States, Canada |
Clinical Success defined as continued improvement or complete resolution of baseline signs and symptoms and if available, an improved/stable chest radiograph after the end of treatment
Clinical Success defined as continued improvement or complete resolution of baseline signs and symptoms and if available, an improved/stable chest radiograph after the end of treatment
| Arm | Type | Description |
|---|---|---|
| Levofloxacin | ACTIVE_COMPARATOR | - |
| CEM-101 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Levofloxacin | DRUG | Levofloxacin once daily for 5 days: Levofloxacin 750 mg PO Days 1-5 |
| CEM-101 | DRUG | CEM-101 once daily for 5 days: CEM-101 800 mg PO Day 1 CEM-101 400 mg PO Days 2-5 |
Inclusion Criteria: 1. Diagnosis of community acquired bacterial pneumonia (e.g. cough with purulent sputum or change in character of sputum consistent with bacterial infection, dyspnea or tachypnea, chest pain due to pneumonia, fever, presence of rales and/or signs of consolidation). 2. No prior s...