drugset / Trial / NCT01811732
Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections
RandomizedParallel-groupTriple-blindTreatment
Summary
This study was designed to evaluate the efficacy of delafloxacin patients with acute bacterial skin and soft tissue infections (ABSSSI).
Timeline
- Start
- 2013-04
- Primary completion
- 2014-07
- Completion
- 2014-07
Publications
- Lodise T, Corey R, Hooper D, Cammarata S. Safety of Delafloxacin: Focus on Adverse Events of Special Interest. Open Forum Infect Dis. 2018 Sep 10;5(10):ofy220. doi: 10.1093/ofid/ofy220. eCollection 2018 Oct.
- Pullman J, Gardovskis J, Farley B, Sun E, Quintas M, Lawrence L, Ling R, Cammarata S; PROCEED Study Group. Efficacy and safety of delafloxacin compared with vancomycin plus aztreonam for acute bacterial skin and skin structure infections: a Phase 3, double-blind, randomized study. J Antimicrob Chemother. 2017 Dec 1;72(12):3471-3480. doi: 10.1093/jac/dkx329.
- McCurdy S, Lawrence L, Quintas M, Woosley L, Flamm R, Tseng C, Cammarata S. In Vitro Activity of Delafloxacin and Microbiological Response against Fluoroquinolone-Susceptible and Nonsusceptible Staphylococcus aureus Isolates from Two Phase 3 Studies of Acute Bacterial Skin and Skin Structure Infections. Antimicrob Agents Chemother. 2017 Aug 24;61(9):e00772-17. doi: 10.1128/AAC.00772-17. Print 2017 Sep.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aztreonam | Small molecule | 2 g | Intravenous |
| Subject | Delafloxacin | Small molecule | 300 mg | Intravenous |
| Comparator | Vancomycin | Other / unclassified | 15 mg/kg | Intravenous |