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A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Oral Omadacycline to Oral Linezolid for Treating Adult Subjects With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

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Trial Profile

A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Oral Omadacycline to Oral Linezolid for Treating Adult Subjects With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jan 2022

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At a glance

  • Drugs Omadacycline (Primary) ; Linezolid
  • Indications Bacterial infections; Skin and soft tissue infections
  • Focus Registrational; Therapeutic Use
  • Acronyms OASIS-2
  • Sponsors Paratek Pharmaceuticals

    • Most Recent Events

    • 11 Jan 2022 Results of pool and post hoc analysis from the Phase 3 studies (NCT02378480 and NCT02877927) assessing the efficacy and safety of omadacycline, versus linezolid, in PWID subgroup and non-PWID subgroup, in acute skin and skin structure infection, published in the Infectious Diseases and Therapy.
    • 17 Jan 2021 Results of post-hoc secondary analysis from OASIS-1 and OASIS-2 published in the Journal of Antimicrobial Chemotherapy
    • 27 Apr 2020 Results published in the Antimicrobial Agents and Chemotherapy
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