Study design

A Phase III, prospective, multicentre (China, Taiwan, Korea, Vietnam and India), randomised, double-blind, non-inferiority with nested superiority trial comparing Zinforo (600 mg IV every 12 hours) vs ceftriaxone (2 g IV every 24 hours)

Patient population

Adult Asian patients ≥18 years of age with PORT risk class III-IV CAP. 763 patients were treated for 5-7 days and evaluated in the MITT population

Study objective

To determine non-inferiority (with nested superiority) in the clinical cure rate of Zinforo compared with ceftriaxone (2 g) in the CE population at TOC (8-15 days after end of treatment)

Secondary objectives

Clinical response at the TOC in the MITT, mMITT, and ME populations; clinical response at EOT; clinical relapse at the LFU visit in patients who were clinically cured at TOC; microbiological response at the TOC; clinical and microbiological response by pathogen at the TOC; and safety (as assessed by adverse events in the safety population)
Clinical cure was defined as total resolution of all signs and symptoms of CAP or improvement to such an extent that further antimicrobial treatment was unnecessary