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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00107978 | Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus | PHASE3 | COMPLETED | 1,035 | — | — | Feb 1, 2005 | May 1, 2006 | Jan 16, 2019 | 1 | United States |
| NCT00091819 | Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus | PHASE3 | COMPLETED | 862 | — | — | Jan 1, 2005 | Jun 1, 2006 | Jan 16, 2019 | 1 | United States |
The Clinical Response for each patient was determined by the investigator by assessing the patient's clinical signs \& symptoms compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.
| Arm | Type | Description |
|---|---|---|
| Telavancin | EXPERIMENTAL | - |
| Vancomycin | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Telavancin | DRUG | Telavancin 10 mg/kg/day, IV for up to 14 days. |
| Vancomycin | DRUG | Vancomycin 1 Gm IV administered every 12 hrs for up to 14 days. |
Inclusion Criteria: * Patients must have a diagnosis of one of the following complicated skin and skin structure infections with MRSA (Methicillin-resistant Staphylococcus Aureus) either suspected or confirmed as the major cause of the infection: * major abscess requiring surgical incision and d...