drugset / Trial / NCT01811732

Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections

NCT01811732 ↗

Phase 3 Completed 660 enrolled Melinta Therapeutics, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

This study was designed to evaluate the efficacy of delafloxacin patients with acute bacterial skin and soft tissue infections (ABSSSI).

Timeline

Start
2013-04
Primary completion
2014-07
Completion
2014-07

Outcome

Met primary endpoint

paper Delafloxacin, an anionic fluoroquinolone, was statistically non-inferior to vancomycin/aztreonam at 48-72 h following the start of therapy PMID 29029278 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aztreonam Small molecule 2 g Intravenous
Subject Delafloxacin Small molecule 300 mg Intravenous
Comparator Vancomycin Other / unclassified 15 mg/kg Intravenous