Omadacycline vs moxifloxacin in adults with community-acquired bacterial pneumonia.
Antoni Torres, Lynne Garrity-Ryan, Courtney Kirsch, Judith N Steenbergen, Paul B Eckburg, Anita F Das, Marla Curran, Amy Manley, Evan Tzanis, Paul C McGovern
Author Information
Antoni Torres: Servei de Pneumologia, Hospital Clinic, Barcelona, Universitat de Barcelona, Spain. Electronic address: atorres@clinic.cat.
Lynne Garrity-Ryan: Paratek Pharmaceuticals, Inc., King of Prussia, PA, USA.
Courtney Kirsch: Paratek Pharmaceuticals, Inc., King of Prussia, PA, USA.
Judith N Steenbergen: Paratek Pharmaceuticals, Inc., King of Prussia, PA, USA.
Paul B Eckburg: Paratek Pharmaceuticals, Inc., King of Prussia, PA, USA.
Anita F Das: AD Stats Consulting, Guerneville, CA, USA.
Marla Curran: Paratek Pharmaceuticals, Inc., King of Prussia, PA, USA.
Amy Manley: Paratek Pharmaceuticals, Inc., King of Prussia, PA, USA.
Evan Tzanis: Paratek Pharmaceuticals, Inc., King of Prussia, PA, USA.
Paul C McGovern: Paratek Pharmaceuticals, Inc., King of Prussia, PA, USA.
OBJECTIVE: Community-acquired bacterial pneumonia (CABP) is a major clinical burden worldwide. In the phase III OPTIC study (NCT02531438) in CABP, omadacycline was found to be non-inferior to moxifloxacin for investigator-assessed clinical response (IACR) at post-treatment evaluation (PTE, 5-10 days after last dose). This article reports the efficacy findings, as specified in the European Medicines Agency (EMA) guidance. METHODS: Patients were randomized 1:1 to omadacycline 100 mg intravenously (every 12 h for two doses, then every 24 h) with optional transition to 300 mg orally after 3 days, or moxifloxacin 400 mg intravenously (every 24 h) with optional transition to 400 mg orally after 3 days. The total treatment duration was 7-14 days. The primary endpoint for EMA efficacy analysis was IACR at PTE in patients with Pneumonia Patient Outcomes Research Team (PORT) risk class III and IV. RESULTS: In total, 660 patients were randomized as PORT risk class III and IV. Omadacycline was non-inferior to moxifloxacin at PTE. The clinical success rates were 88.4% and 85.2%, respectively [intent-to-treat population; difference 3.3; 97.5% confidence interval (CI) -2.7 to 9.3], and 92.5% and 90.5%, respectively (clinically evaluable population; difference 2.0; 97.5% CI 3.2-7.4). Clinical success rates with omadacycline and moxifloxacin were similar against identified pathogens and across key subgroups. CONCLUSIONS: Omadacycline was non-inferior to moxifloxacin for IACR at PTE, with high clinical success across pathogen types and patient subgroups.
