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)

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)

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Apr 2018

At a glance

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

    • 12 Apr 2018 According to a Paratek Pharmaceuticals media release, data from this study will be presented at the annual meeting of the European Congress of Clinical Microbiology and Infectious Diseases, ECCMID 2018.
    • 04 Apr 2018 According to a Paratek Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has accepted two New Drug Applications (NDAs) and granted a priority review for omadacycline for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). PDUFA Action Date is in October 2018. The FDA is currently planning to hold an advisory committee meeting to review these applications.
    • 01 Mar 2018 Data from this trial will be presented at the upcoming European Congress of Clinical Microbiology and Infectious Disease (April 2018), according to a Paratek Pharmaceuticals media release.
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