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
Journal
Journal of Microbiology, Immunology and Infection
Journal Volume
52
Journal Issue
1
Pages
35-44
Date Issued
2019
Author(s)
Yuan J.
Mo B.
Ma Z.
Lv Y.
Cheng S.-L.
Yang Y.
Tong Z.
Wu R.
Sun S.
Cao Z.
Wu J.
Zhu D.
Chang L.
Zhang Y.
Zhao L.
Wang X.
Wang X.
Wang D.
Li X.
Peng Y.
Liang Y.
Liu H.
Xiao Z.
Lv X.
Wu S.
Dai Y.
Huang Y.
Hu Z.
Qiu C.
Li X.
Zhang S.
Li W.
Liu S.
Shi Y.
Xiong C.
Kuang J.
Xiu Q.
Cui S.
Li J.
Lin Q.
Huang W.
Wan Y.
Qimanguli, Shen C.
Xiao Y.
Wu X.
Chuang Y.C.
Perng W.C.
Tsao S.-M.
Hsu J.-Y.
Wang C.-C.
Wang J.-H.
Yeh P.-F.
Lin H.-H.
Lin M.-S.
Su W.-J.
Investigator Group of the Phase 3 Study on Oral Nemonoxacin
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. ? 2018
Subjects
Clinical outcome; Community-acquired pneumonia; Levofloxacin; Nemonoxacin; Randomized controlled trial; Safety
SDGs
Other Subjects
alanine aminotransferase; aspartate aminotransferase; bilirubin; bilirubin glucuronide; levofloxacin; nemonoxacin; antiinfective agent; levofloxacin; nemonoxacin; quinolone derivative; abdominal discomfort; adult; alanine aminotransferase blood level; antibiotic therapy; Article; aspartate aminotransferase blood level; bilirubin blood level; bradycardia; Chlamydia pneumoniae; clinical outcome; community acquired pneumonia; controlled study; coughing; crackle; disease severity; dizziness; double blind procedure; drug efficacy; drug safety; drug withdrawal; dyspnea; female; fever; Haemophilus; heart arrest; human; hyperbilirubinemia; hypertransaminasemia; intention to treat analysis; Klebsiella; Legionella pneumophila; leukocyte count; major clinical study; male; methicillin resistant Staphylococcus aureus; MIC50; MIC90; multicenter study; Mycoplasma pneumoniae; nausea; non-inferiority trial; phase 3 clinical trial; randomized controlled trial; rash; second degree atrioventricular block; side effect; Streptococcus pneumoniae; thorax pain; treatment duration; vomiting; bacterial pneumonia; clinical trial; community acquired infection; comparative study; drug effect; microbial sensitivity test; microbial viability; middle aged; oral drug administration; safety; treatment outcome; Administration, Oral; Adult; Anti-Bacterial Agents; Community-Acquired Infections; Double-Blind Method; Female; Humans; Levofloxacin; Male; Microbial Sensitivity Tests; Microbial Viability; Middle Aged; Pneumonia, Bacterial; Quinolones; Safety; Treatment Outcome
Publisher
Elsevier Ltd
Type
journal article