Safety and efficacy of nemonoxacin versus levofloxacin in the treatment of community-acquired pneumonia: results of phase III, multicenter, randomized, double-blind, active-controlled, non-inferiority trial

Abstract

Objective. To evaluate the efficacy and safety of a step-down strategy from intravenous to oral nemonoxacin versus a step-down strategy from intravenous to oral levofloxacin in the treatment of patients with community-acquired pneumonia. Materials and Methods. This was a phase III randomized, controlled, double-blind, double-dummy, parallel groups (2 groups), multicenter trial to evaluate the efficacy and safety of intravenous and oral nemonoxacin at a daily dose of 500 mg versus levofloxacin (Tavanic®) at a daily dose of 500 mg in the treatment of adult patients with community-acquired pneumonia. A total of 342 patients from 25 sites were randomized with 171 patients in the control group and 171 patients in the study group. Results. A total of 169 patients in the nemonoxacin group and 166 patients in the levofloxacin group received at least one dose of the study drug and were clinically evaluable (mITT, modified intention-to-treat population). At the test-of-cure visit, the clinical cure rates were 93.5% and 87.3% in the nemonoxacin and levofloxacin groups, respectively (the difference in clinical success rates was 6.1% [95% CI: -0.7–13.0%]). The median time to switching to oral therapy was 4 days in both groups. Two (1.2%) and five (3.0%) patients out of 169 and 166 patients in the nemonoxacin and levofloxacin groups, respectively, required treatment with other antibiotics, the difference being insignificant (p = 0,259). The microbiological efficacy cannot be evaluated reliably due to an insignificant number of positive microbiological results. The incidence of drug-related adverse events (ADR) was 38.0% and 20.7% in the nemonoxacin and levofloxacin groups, respectively. After switching to oral treatment, the incidence of ADR was comparable between the study and control groups constituting 8.8% and 8.9%, respectively. Conclusions. Clinically, a step-down therapy with nemonoxacin at a dose of 500 mg once daily was noninferior compared with step-down therapy with levofloxacin at a dose of 500 mg once daily.

Keywords

• nemonoxacin
• levofloxacin
• community-acquired pneumonia
• efficacy
• safety
• clinical trial