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Clinical Trial
. 2019 Feb;52(1):35-44.
doi: 10.1016/j.jmii.2017.07.011. Epub 2017 Aug 2.

Safety and Efficacy of Oral Nemonoxacin Versus Levofloxacin in Treatment of Community-Acquired Pneumonia: A Phase 3, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Non-Inferiority Trial

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Clinical Trial

Safety and Efficacy of Oral Nemonoxacin Versus Levofloxacin in Treatment of Community-Acquired Pneumonia: A Phase 3, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Non-Inferiority Trial

Jinyi Yuan et al. J Microbiol Immunol Infect. .
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Abstract

Background/purpose: Nemonoxacin is a novel nonfluorinated quinolone with excellent in vitro activity against most pathogens in community-acquired pneumonia (CAP), especially Gram-positive isolates. The purpose of this study was to assess the efficacy and safety of nemonoxacin compared with levofloxacin in patients with CAP.

Methods: A phase 3, multicenter, randomized (2:1) controlled trial was conducted in adult CAP patients receiving nemonoxacin 500 mg or levofloxacin 500 mg orally once daily for 7-10 days. Clinical, microbiological response and adverse events were assessed. Non-inferiority was determined in terms of clinical cure rate of nemonoxacin compared with that of levofloxacin in a modified intention-to-treat (mITT) population. NCT registration number: NCT01529476.

Results: A total of 527 patients were randomized and treated with nemonoxacin (n = 356) or levofloxacin (n = 171). The clinical cure rate at test-of-cure visit was 94.3% (300/318) for nemonoxacin and 93.5% (143/153) for levofloxacin in the mITT population [difference (95% CI), 0.9% (-3.8%, 5.5%)]. The microbiological success rate was 92.1% (105/114) for nemonoxacin and 91.7% (55/60) for levofloxacin in the bacteriological mITT population [difference (95% CI), 0.4% (-8.1%, 9.0%)]. The incidence of adverse events (AEs) was comparable between nemonoxacin (33.1%, 118/356) and levofloxacin (33.3%, 57/171) (P > 0.05).

Conclusion: Nemonoxacin 500 mg once daily for 7-10 days is as effective and safe as levofloxacin for treating adult CAP patients in terms of clinical cure rates, microbiological success rates, and safety profile. ClinicalTrials.gov identifier: NCT01529476.

Keywords: Clinical outcome; Community-acquired pneumonia; Levofloxacin; Nemonoxacin; Randomized controlled trial; Safety.

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