A Phase 3 Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Linezolid IV/PO for Treating Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Trial Profile

A Phase 3 Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Linezolid IV/PO for Treating Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Oct 2017

At a glance

  • Drugs Omadacycline (Primary) ; Omadacycline (Primary) ; Linezolid; Linezolid
  • Indications Bacterial infections; Skin and soft tissue infections
  • Focus Registrational; Therapeutic Use
  • Acronyms OASIS; OASIS-1
  • Sponsors Paratek Pharmaceuticals
  • Most Recent Events

    • 08 Oct 2017 Results assessing the cardiovascular safety profile of Omadacycline in the phase 3 OPTIC and OASIS-1 studies presented at the IDWeek 2017
    • 08 Oct 2017 Results of subgroup analysis assessing efficacy and safety of Omadacycline vs Linezolid in intravenous drug using and Hepatitis C-Positive + patients from OASIS presented at the IDWeek 2017
    • 08 Oct 2017 Results of subgroup analysis evaluating the efficacy and safety of Omadacycline vs linezolid in patients with stage 1 Chronic Kidney Disease (CKD) (CKD-1; GFR greater than or equals 90 mL/min) or stage 2/3 CKD (CKD-2/3; GFR = 30-89 mL/min) from OASIS presented at the IDWeek 2017
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