A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline Intravenous (IV)/Oral (PO) to Moxifloxacin IV/PO for Treating Adults Subjects With Community-Acquired Bacterial Pneumonia

Trial Profile

A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline Intravenous (IV)/Oral (PO) to Moxifloxacin IV/PO for Treating Adults Subjects With Community-Acquired Bacterial Pneumonia

Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jun 2018

At a glance

  • Drugs Omadacycline (Primary) ; Omadacycline (Primary) ; Moxifloxacin; Moxifloxacin
  • Indications Bacterial infections; Community-acquired pneumonia
  • Focus Registrational; Therapeutic Use
  • Acronyms OPTIC
  • Sponsors Paratek Pharmaceuticals
  • Most Recent Events

    • 20 Jun 2018 According to a Paratek Pharmaceuticals media release, the US FDA has scheduled a meeting of the Antimicrobial Drugs Advisory Committee to review the NDAs for omadacycline for the treatment of CABP and ABSSSI on 8 August 2018.
    • 23 May 2018 Results assessing Early Clinical Response of Omadacycline Versus Moxifloxacin, presented at the 114th International Conference of the American Thoracic Society
    • 22 May 2018 According to a Paratek Pharmaceuticals media release, data from this study were presented during "New Insights in Acute Pulmonary Infections" Oral Session at American Thoracic Society 2018 International Conference.
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