RE: RNS 03Oct 2018.3 Oct 2018 09:23
........"A post-hoc analysis was conducted on the pooled data from the REVIVE-1 and REVIVE-2 Phase 3 trials to evaluate the safety and efficacy of iclaprim compared to vancomycin, the current standard of care, in treating wound infections, including surgical site infections. Fifty percent (602/1198) of the REVIVE intent-to-treat (ITT) population had wound infections. Iclaprim achieved non-inferiority to vancomycin, based on early clinical response at the early time point in the subgroup of patients with wound infections. Iclaprim and vancomycin had similar adverse event profiles in patients with wound infections. Two vancomycin-treated patients and no iclaprim-treated patients had serum creatinine levels ≥3 x upper limit of normal, indicating potential nephrotoxicity, a toxicity known to occur with vancomycin administration."....