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
Latest Information Update: 23 Jul 2024
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
- 18 Jul 2024 According to a Paratek Pharmaceuticals media release, company intend to submit the study report to the FDA and engage in label update negotiations later this year (as Early as 4Q2024).
- 18 Jul 2024 According to a Paratek Pharmaceuticals media release, results from this trial were published in The New England Journal of Medicine in 2019.
- 01 May 2021 Results of subgroup analysis assessing the safety and efficacy of omadacycline and moxifloxacin by BMI categories in adult patients with community acquired bacterial pneumonia, published in the Respiratory Medicine.