drugset / Trial / NCT02600611
Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-1
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin for the treatment of skin and skin structure infections.
Timeline
- Start
- 2015-11-01
- Primary completion
- 2017-01-30
- Completion
- 2017-01-30
Publications
- Huang DB, Corey GR, Holland TL, Lodise T, O'Riordan W, Wilcox MH, File TM Jr, Dryden M, Balser B, Desplats E, Torres A. Pooled analysis of the phase 3 REVIVE trials: randomised, double-blind studies to evaluate the safety and efficacy of iclaprim versus vancomycin for treatment of acute bacterial skin and skin-structure infections. Int J Antimicrob Agents. 2018 Aug;52(2):233-240. doi: 10.1016/j.ijantimicag.2018.05.012. Epub 2018 May 19.
- Huang DB, O'Riordan W, Overcash JS, Heller B, Amin F, File TM, Wilcox MH, Torres A, Dryden M, Holland TL, McLeroth P, Shukla R, Corey GR. A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim Vs Vancomycin for the Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed to be Due to Gram-Positive Pathogens: REVIVE-1. Clin Infect Dis. 2018 Apr 3;66(8):1222-1229. doi: 10.1093/cid/cix987.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Vancomycin | Other / unclassified | 15 mg/kg | Intravenous |
| Subject | iclaprim | Small molecule | 80 mg | Intravenous |
Indications
No indication recorded.