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
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 07 Nov 2021
Price :
$35
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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
- 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.
- 21 Oct 2020 Results (n=74) of sub-analysis presented at the CHEST Annual Meeting 2020 by Annual Meeting of the American College of Chest Physicians .
- 17 Oct 2019 According to a Paratek Pharmaceuticals media release, the company plans to re-submit application to EMA following completion of the planned Post-Marketing Approval CABP study already agreed with the FDA.