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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00646958 | Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections | PHASE2 | COMPLETED | 150 | — | — | Dec 1, 2007 | Apr 1, 2008 | Mar 27, 2014 | 19 | United States |
To qualify as a Cure, participants were required to fulfill the following criteria: all systemic signs and symptoms of uSSSI present at screening were improved or resolved; no further antibiotic therapy was necessary for treatment of uSSSI; and there was no worsening or appearance of new signs and symptoms of uSSSI.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Radezolid 450 mg PO QD |
| 2 | EXPERIMENTAL | Radezolid 450 mg PO BID |
| 3 | ACTIVE_COMPARATOR | Linezolid 600 mg PO BID |
| Name | Type | Description |
|---|---|---|
| Radezolid | DRUG | 450mg PO QD |
| Linezolid | DRUG | 600mg PO BID |
Inclusion Criteria: * Adult patients with uSSSI * Adult (men and women) ≥18 years * Females must be post-menopausal for at least 1 year or surgically sterile * Sexually active males must use a barrier method of birth control during and for 30 days after the study * Acceptable clinical diagnoses of ...