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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: 16 Apr 2019

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

    • 16 Apr 2019 Results assessing the safety and efficacy of omadacycline by renal function using data from OASIS-1, OASIS-2 and OPTIC studies, presented at the 29th European Congress of Clinical Microbiology and Infectious Diseases
    • 16 Apr 2019 Results assessing early clinical response and clinical stability as predictors of overall clinical response, presented at the 29th European Congress of Clinical Microbiology and Infectious Diseases
    • 16 Apr 2019 Results assessing the safety and efficacy of omadacycline by body mass index in patients with community-acquired bacterial pneumonia, presented at the 29th European Congress of Clinical Microbiology and Infectious Diseases
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