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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00772447 | China Registration Study in Patients With Skin Infections | PHASE3 | COMPLETED | 265 | — | — | Sep 1, 2008 | Sep 1, 2010 | Mar 9, 2015 | 13 | China |
Erythrocyte volume fraction means under certain conditions, after centrifugation pressing, the percentage of erythrocyte volume in the total volume of blood
percentage of patients who were primarily tested as normal ECG at baseline and changed into abnormal ECG at TOC visit in all the patients with normal ECG at baseline
| Arm | Type | Description |
|---|---|---|
| AZ drug | EXPERIMENTAL | Daptomycin |
| Comparator | ACTIVE_COMPARATOR | Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin |
| Name | Type | Description |
|---|---|---|
| Daptomycin | DRUG | 4mg/kg IV ; Q 24 hr (once every 24 hours) |
| Vancomycin | DRUG | Vancomycin - 1g per 12 hrs, for 7-14 days Or switch to Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin: \- 1 g every 6 hours or 2 g every 8 hours |
Inclusion Criteria: * Provision of inform consent * A diagnosis of of complicated skin and skin structure infection known or suspected to be due to Gram-positive bacteria * Diagnosis of bacterial skin and skin structure infection in the presence of some complicating factor, including infections inv...