Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus
Vancomycin for ABSSSI: REVIVE-2 (REVIVE-2)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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ClinicalTrials.gov Identifier: NCT02607618
First Posted : November 18, 2015
Results First Posted : July 11, 2018
Last Update Posted : August 7, 2018
Information provided by (Responsible Party):
Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Skin Structures and Soft Tissue Infections
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
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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). pii: e02580-17. doi: 10.1128/AAC.02580-17. Print 2018 May.
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History of Changes
Other Study ID Numbers:
November 13, 2015
November 18, 2015
Results First Submitted:
June 14, 2018
Results First Posted:
July 11, 2018
Last Update Posted:
August 7, 2018