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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01499277 | Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections | PHASE3 | COMPLETED | 802 | — | — | May 1, 2012 | Jan 1, 2015 | Sep 6, 2017 | 91 | United States, Argentina +26 |
The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.
The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.
| Arm | Type | Description |
|---|---|---|
| Ceftaroline fosamil | EXPERIMENTAL | Patients will receive 600 mg of ceftaroline fosamil administered as a 120-minute intravenous infusion very 8 hours. Each dose will be infused in a volume of 250 mL over 120-minutes followed by aztreonam placebo in a volume of 100 mL infused over 30 minutes every 8 hours. In addition vancomycin placebo will be given in a volume of 250 mL infused over 120 minutes every 12 hours. Doses will be adjusted according to the patient's renal function. |
| Vancomycin plus aztreonam | ACTIVE_COMPARATOR | Patients will receive combination of vancomycin plus aztreonam. Dose of vancomycin will be based on the patient's actual weight and will receive intravenous vancomycin every 12 hours with each dose infused over 120-minutes. Aztreonam dose will be 1 gram intravenously in a volume of 100 mL infused over 30 minutes every 8 hours. In addition, ceftaroline fosamil placebo will be given in a volume of 250 mL infused over 120 minutes every 8 hours. Doses adjusted according to patients renal function |
| Name | Type | Description |
|---|---|---|
| Ceftaroline fosamil | DRUG | IV ceftaroline 600mg every 8 hours |
| Vancomycin | DRUG | IV vancomycin 15mg/kg every 12 hours |
| Aztreonam | DRUG | IV aztreonam 1 g every 8 hours |
Inclusion Criteria: * Male or female, aged 18 years or older * Complicated skin and skin structure infection (cSSTI) * Infection of sufficient severity to warrant hospitalization * Infection of sufficient severity such that it is expected to require at least 5 days of intravenous antibiotic therapy...