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: 18 Jul 2017

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

    • 02 Jun 2017 Status changed from active, no longer recruiting to completed.
    • 31 May 2017 This has been competed in Croatia as per European Clinical Trials Database.
    • 03 Apr 2017 Primary endpoint (Non-inferiority in the ITT and CE CABP populations in those patients with Pneumonia Severity Index (PORT) III and IV at the PTE time point ) has been met, according to a Paratek Pharmaceuticals media release.
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