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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01968733 | Efficacy and Safety Study of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia | PHASE3 | COMPLETED | 863 | — | — | Nov 1, 2013 | Sep 1, 2015 | Mar 3, 2017 | 270 | United States, Argentina +24 |
| NCT01756339 | Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia | PHASE3 | COMPLETED | 860 | — | — | Dec 1, 2012 | Oct 1, 2014 | Mar 3, 2017 | 119 | United States, Argentina +15 |
To determine noninferiority (NI) in early clinical response rate, in at least 2 of the following 4 cardinal symptoms: cough, shortness of breath, chest pain, and sputum production
To determine noninferiority (NI) in early clinical response rate, in at least 2 of the following 4 cardinal symptoms: cough, shortness of breath, chest pain, and sputum production.
| Arm | Type | Description |
|---|---|---|
| Moxifloxacin | ACTIVE_COMPARATOR | Intravenous with the potential step-down to oral moxifloxacin |
| Solithromycin | EXPERIMENTAL | Intravenous with potential step-down to oral solithromycin |
| Name | Type | Description |
|---|---|---|
| Solithromycin | DRUG | - |
| Moxifloxacin | DRUG | - |
| Placebo to match solithromycin | OTHER | - |
Inclusion Criteria: * Male and female patients ≥ 18 years of age * An acute onset of at least 3 of the following signs and symptoms (new or worsening): 1. Cough 2. Production of purulent sputum 3. Shortness of breath (dyspnea) 4. Chest pain due to pneumonia * At least 1 of the following: ...