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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01371838 | A Study to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia | PHASE3 | COMPLETED | 848 | — | — | Dec 1, 2011 | May 1, 2013 | Sep 6, 2017 | 43 | China, India +3 |
Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary Failure: Any of the following: •Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy •Treatment-limiting AE leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia •Death wherein pneumonia (ie,CABP) was considered causative Indeterminate: Inability to determine an outcome
| Arm | Type | Description |
|---|---|---|
| Ceftaroline | EXPERIMENTAL | - |
| Ceftriaxone plus placebo | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Ceftaroline | DRUG | Two consecutive infusions q12h for 5 to 7 days |
| Ceftriaxone | DRUG | One dose infusion followed by IV saline placebo infused q24h for 5 to 7 days plus two consecutive saline placebo infusion q24h. |
Inclusion Criteria: * Males and females 18 or more years of age * Lung Infection of Individual not Recently Hospitalized meeting the following criteria: Radiographically-confirmed pneumonia (new or progressive infection site of the lungs) consistent with bacterial pneumonia), AND Acute illness (≤ 7...