drugset / Trial / NCT02607618
Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-2
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
- Primary completion
- 2017-08-08
- Completion
- 2017-08-08
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.
- Holland TL, O'Riordan W, McManus A, Shin E, Borghei A, File TM Jr, Wilcox MH, Torres A, Dryden M, Lodise T, Oguri T, Corey GR, McLeroth P, Shukla R, Huang DB. A Phase 3, Randomized, Double-Blind, Multicenter Study To Evaluate the Safety and Efficacy of Intravenous Iclaprim versus Vancomycin for Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed To Be Due to Gram-Positive Pathogens (REVIVE-2 Study). Antimicrob Agents Chemother. 2018 Apr 26;62(5):e02580-17. doi: 10.1128/AAC.02580-17. Print 2018 May.
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.