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
| Autor: | Pen-Fang Yeh, Biwen Mo, Zhuang Ma, Xuefen Wang, Wei-Juin Su, Jeng-Yuan Hsu, Xiangyang Li, Li Zhao, Demei Zhu, Chen Qiu, Liwen Chang, Chang Xiong, Shih-Lung Cheng, Ce Shen, Chin-Chou Wang, Qimanguli, Jianguo Li, P.H. Kuo, Hua Liu, Yin Ching Chuang, Xiaoju Wu, Zhaolong Cao, Xiaoju Lv, Dexi Wang, Wenxiang Huang, Yanping Yang, Shiman Wu, Yongjie Liang, Yijiang Huang, Wenpu Li, Yiqiang Peng, Jinyi Yuan, Yixin Wan, Yuanrong Dai, Zhaohui Tong, Wann Cherng Perng, Shih-Ming Tsao, Qingyu Xiu, Shenghua Sun, His-Hsun Lin, Renguang Wu, Shuang Liu, Yingyuan Zhang, Xi Li, Suiyang Zhang, Jen Hsien Wang, Ming-Shian Lin, Yi Xiao, Zhenghong Hu, Yi Shi, Xiongbiao Wang, Shehuai Cui, Yuan Lv, Jufang Wu, Zuke Xiao, Jiulong Kuang, Qichang Lin |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Microbiology (medical) Adult Male medicine.medical_specialty 030106 microbiology Population lcsh:QR1-502 Administration Oral Levofloxacin Microbial Sensitivity Tests Quinolones lcsh:Microbiology law.invention 03 medical and health sciences chemistry.chemical_compound Community-acquired pneumonia Randomized controlled trial Double-Blind Method law Internal medicine medicine Pneumonia Bacterial Immunology and Allergy Humans education Adverse effect education.field_of_study Microbial Viability General Immunology and Microbiology business.industry Incidence (epidemiology) General Medicine Middle Aged medicine.disease Surgery Anti-Bacterial Agents Community-Acquired Infections Pneumonia Infectious Diseases Treatment Outcome chemistry Female Safety business Nemonoxacin medicine.drug |
| Zdroj: | Journal of Microbiology, Immunology and Infection, Vol 52, Iss 1, Pp 35-44 (2019) |
| ISSN: | 1995-9133 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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