A Phase 3, Randomized, double-blind, multicenter study to EValuate the safety and efficacy of intravenous Iclaprim versus Vancomycin for the trEatment of acute bacterial skin and skin structure infections suspected or confirmed to be due to Gram-positive pathogens: REVIVE-2 [PublishAheadOfPrint]

Iclaprim is a novel diaminopyrimidine antibiotic that may be an effective and safe treatment for serious skin infections. The safety and effectiveness of iclaprim were assessed in a global Phase 3, double-blind, randomized, active-controlled trial. Six-hundred thirteen adults with acute bacterial skin and skin structure infections (ABSSSI) suspected or confirmed to be due to Gram-positive pathogens were randomized to iclaprim (80 mg) or vancomycin (15mg/kg), both administered intravenously every 12 hours for 5 - 14 days. The primary endpoint was a ≥20% reduction in lesion size, compared with baseline, at 48 to 72 hours after the start of administration of study drug in the intent-to-treat population. Among patients randomized to iclaprim, 78.3% (231 of 295) met this primary endpoint, compared with 76.7% (234 of 305) for those receiving vancomycin (treatment difference: 1.58%, 95% CI: -5.10% to 8.26%). This met the pre-specified 10% non-inferiority margin. Iclaprim was well tolerated, with most adverse events categorized as mild. In conclusion, iclaprim was non-inferior to vancomycin in this Phase 3 clinical trial for the treatment of acute bacterial skin and skin structure infections. Based on these results, iclaprim may be an efficacious and safe treatment for skin infections suspected or confirmed to be due to Gram-positive pathogens.

(This trial has ben registered at ClinicalTrials.gov under identifier NCT02607618.)

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