Table 1.
Description of Phase 2 and Phase 3 Clinical Acute Bacterial Skin and Skin Structure Infection Studies
| No. of Subjects (N = 1840)a | ||||
|---|---|---|---|---|
| Study Number | Title | Delafloxacin (n = 868) | Comparator (n = 972) | Dose |
| RX-3341-201[5] | A Randomized, double-blind, multicenter study of the safety and efficacy of RX-3341 compared with tigecycline for the treatment of complicated skin and skin structure infections | 49 | 50 | Delafloxacin: 300 or 450 mg BID IV tigecycline: 100 loading and 50 mg BID IV (Multiple dose: 5–14 d) |
| RX-3341-202[6] | A phase 2 exploratory study of objective endpoints in subjects with acute bacterial skin and skin structure infections treated with delafloxacin, vancomycin, or linezolid | 78 | 171 | Delafloxacin: 300 mg BID IV vancomycin: 15 mg/kg BID or local standard of care linezolid 600 mg BID IV (with concomitant aztreonam in linezolid and vancomycin subjects) (Multiple dose: 5–14 d) |
| RX-3341-302[7] | Phase 3, multicenter, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of delafloxacin compared with vancomycin + aztreonam in patients with acute bacterial skin and skin structure infections | 324 | 326 | Delafloxacin: 300 mg IV in a 1-hour infusion every 12 hrs. Vancomycin: 15 mg/kg every 12 hrs (with concomitant aztreonam) (Multiple dose: 5–14 d) |
| RX-3341-303[4] | Phase 3, multicenter, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of IV and oral delafloxacin compared with vancomycin + aztreonam in patients with acute bacterial skin and skin structure infections | 417 | 425 | Delafloxacin: 300 mg IV in a 1-hour infusion every 12 hrs for 6 doses then 450 mg oral every 12 hrs. Vancomycin: 15 mg/kg every 12 hrs or local standard of care (with concomitant aztreonam) (Multiple dose: 5–14 d) |
RX-3341-201 also enrolled 51 patients who received 450 mg IV Q12h delafloxacin for 5 to 14 days; the data for these patients at the 450-mg IV Q12h dose are not included in the pooled multiple dose analysis set because the 450-mg IV dose provides higher exposure than planned with the marketed 300-mg IV dose.
Abbreviations: BID, two times a day; IV, intravenous.
aSubjects had to receive at least 1 dose in a treatment.