EARLY AND EFFECTIVE CLINICAL SUCCESS IN CABP

OPTIC study design (N=774)1,2

  • OPTIC, known as Trial 1 in the NUZYRA Prescribing Information, was a randomized, multinational, double-blind, double-dummy trial comparing the noninferiority of NUZYRA vs moxifloxacin
  • The trial compared NUZYRA 100 mg intravenously every 12 hours for 2 doses on Day 1, followed by 100 mg intravenously, or 300 mg orally, daily to moxifloxacin 400 mg intravenously or orally daily in the treatment of adults with CABP. Patients could not switch to oral therapy until Day 4. Total treatment duration was 7 to 14 days.

Clinical success in CABP

Bar chart of early clinical response 72-120 hours after the first dose in ITT population showing 81% response with NUZYRA and 83% response with moxifloxacin.
Bar chart of post therapy evaluation 5-10 days after last dose in ITT population showing 88% response with NUZYRA and 85% response with moxifloxacin.
Bar chart of post therapy evaluation 5-10 days after last dose in CE population showing 93% response with NUZYRA and 90% response with moxifloxacin.

ENDPOINTS1,2

  • Primary endpoint at ECR (early clinical response, 72 to 120 hours after the first dose) was defined as survival with improvement in ≥2 of 4 symptoms (cough, sputum production, chest pain, dyspnea) without deterioration in any of these 4 symptoms, and without receiving rescue antibacterial treatment. The primary endpoint was evaluated in the ITT population
  • Secondary endpoint at PTE (post therapy evaluation, 5 to 10 days after last dose) was defined as survival and improvement in signs and symptoms of CABP, based on the clinician’s judgment, to the extent that further antibacterial therapy is not necessary, and the infection was considered clinically cured. The secondary endpoint was evaluated in the ITT and in the CE populations

STUDY POPULATIONS1,2

  • Intent-to-treat (ITT) population was defined as all randomized patients
  • Clinically evaluable (CE) population was defined as all ITT patients who met inclusion criteria and completed the trial
  • Microbiological ITT (micro-ITT) population was defined as all randomized patients who had a causative pathogen at baseline

CLINICAL SUCCESS RATES BY PATHOGEN AT PTE IN CABP1,a

PATHOGEN NUZYRA

% (n/N)

MOXIFLOXACIN

% (n/N)

Streptococcus pneumoniae 86% (37/43) 91% (31/34)
Methicillin-susceptible Staphylococcus aureus (MSSA) 73% (8/11) 80% (8/10)
Haemophilus influenzae 81% (26/32) 100% (16/16)
Haemophilus parainfluenzae 83% (15/18) 77% (13/17)
Klebsiella pneumoniae 77% (10/13) 85% (11/13)
Legionella pneumophila 93% (27/29) 96% (27/28)
Mycoplasma pneumoniae 89% (31/35) 86% (25/29)
Chlamydophila pneumoniae 93% (14/15) 93% (13/14)

aInvestigator’s overall assessment of clinical response at PTE by baseline pathogen in OPTIC (micro-ITT population).