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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01519778 | A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study | PHASE2 | COMPLETED | 200 | — | — | Feb 15, 2012 | Aug 27, 2012 | Aug 29, 2018 | 10 | United States |
Safety will be assessed through summaries of the incidence of AEs and SAEs as well as through summaries of vital signs, physical examinations, ECG findings, and laboratory assessments (hematology, serum chemistry, and urinalysis).
| Arm | Type | Description |
|---|---|---|
| TR-701 FA | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| TR701 FA | DRUG | 1 tablet 200 mg once daily |
Inclusion Criteria: * Male or female patients ≥ 18 years of age * Suspected or documented gram-positive infection from baseline Gram stain or culture. * Cellulitis/erysipelas or major cutaneous abscesses at Screening Exclusion Criteria: * Postsurgical or open wound infections * Severe sepsis or s...