A randomized, double-blind, multicenter Phase II study comparing the efficacy and safety of oral nemonoxacin with oral levofloxacin in the treatment of community-acquired pneumonia

Liu, Yang; Zhang, Yingyuan; Wu, Jiang; Zhu, Demei; Sun, Shenghua; Zhao, Li; Wang, Xuefeng; Liu, Hua; Ren, Zhen-yi; Wang, Changzheng; Xiu, Qingyu; Xiao, Zuke; Zong-xun, Cao; She-huai, Cui; Yang, Heping; Liang, Yongjie; Chen, Ping; Lv, Yuan; Hu, Chengping; Lv, Xiaoju; Liu, Shuang; Kuang, Jiulong; Li, Jianguo; Wang, Dexi; Chang, Li-Wen

doi:10.1016/j.jmii.2015.09.005

Cited by 29 publications

(46 citation statements)

References 16 publications

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“…The recovery rate for typical pathogens was 29.3% (290/989). These results were consistent with those observed in other CAP studies [38][39][40][41][42]. The most commonly identified pathogens in all randomized patients were K. pneumoniae, S. pneumoniae, Haemophilus species, and S. aureus (Figure 1).…”

Section: Overall Recovery Ratesupporting

confidence: 91%

“…An integrated analysis of one Phase III (registration number: NCT01529476) and two Phase II studies (registration numbers: NCT00434291 and NCT01537250) was conducted to compare the commercial dose of oral NEMO 500 mg vs. oral levofloxacin (LEVO) 500 mg for CAP treatment [37][38][39]. This article will review the integrated efficacy results of NEMO vs. LEVO against the common respiratory pathogens isolated from the three Phase II-III trials.…”

Section: Introductionmentioning

confidence: 99%

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Nemonoxacin (Taigexyn^®): A New Non-Fluorinated Quinolone

Chang¹,

Hsu²,

Zhang³

2020

Staphylococcus and Streptococcus

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Nemonoxacin (Taigexyn ® ), a novel C-8-methoxy non-fluorinated quinolone, has been approved for use in community-acquired pneumonia (CAP) in Taiwan (2014) and mainland China (2016). The FDA granted nemonoxacin 'qualified infectious disease product' and 'fast-track' designations for CAP and acute bacterial skin and skin structure infection in December 2013. It possesses a broad spectrum of bactericidal activity against typical and atypical respiratory pathogens. In particular, nemonoxacin has activity against resistant Gram-positive cocci, including penicillin-resistant Streptococcus pneumoniae and methicillinresistant Staphylococcus aureus. Oral nemonoxacin was compared with oral levofloxacin for efficacy and safety in three randomized, double-blinded, controlled Phase II-III clinical trials for the treatment of CAP. This article will review the microbiological profile of nemonoxacin against respiratory pathogens including S. pneumoniae and S. aureus, and microbiological outcome data from the three Phase II-III studies.

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Section: Overall Recovery Ratesupporting

confidence: 91%

Section: Introductionmentioning

confidence: 99%

Nemonoxacin (Taigexyn^®): A New Non-Fluorinated Quinolone

Chang¹,

Hsu²,

Zhang³

2020

Staphylococcus and Streptococcus

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“…Nemonoxacin is a novel nonfluorinated quinolone with a wide antimicrobial spectrum covering Gram-positive cocci and Gram-negative bacilli, including the common CAP pathogens. One published phase 2 trial and two unpublished phase 3 trials suggest that Nemonoxacin is non-inferior to levofloxacin for the treatment of CAP [92,93].…”

Section: The Evidencementioning

confidence: 99%

Challenges in severe community-acquired pneumonia: a point-of-view review

et al. 2019

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Purpose: Severe community-acquired pneumonia (SCAP) is still associated with substantial morbidity and mortality. In this point-of-view review paper, a group of experts discuss the main controversies in SCAP: the role of severity scores to guide patient settings of care and empiric antibiotic therapy; the emergence of pathogens outside the core microorganisms of CAP; viral SCAP; the best empirical treatment; septic shock as the most lethal complication; and the need for new antibiotics. Methods: For all topics, the authors describe current controversies and evidence and provide recommendations and suggestions for future research. Evidence was based on meta-analyses, most recent RCTs and recent interventional or observational studies. Recommendations were reached by consensus of all the authors. Results and conclusions: The IDSA/ATS criteria remain the most pragmatic tool to predict ICU admission. The authors recommend a combination of a beta-lactam/beta-lactamase inhibitor or a third G cephalosporin plus a macrolide in most SCAP patients, and to empirically cover PES (P. aeruginosa, extended spectrum beta-lactamase producing Enterobacteriaceae, methicillin-resistant S. aureus) pathogens when at least two specific risk factors are present. In patients with influenza CAP, the authors recommend the use of oseltamivir and avoidance of the use of steroids. Corticosteroids can be used in case of refractory shock and high systemic inflammatory response.

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“…Different Phase II and III clinical trials have investigated the clinical efficacy and safety of nemonoxacin in the treatment of CAP in comparison with levofloxacin. [48][49][50][51] A recent meta-analysis of most recent phase III trial found that nemonoxacin and levofloxacin had similar clinical cure rates in the treatment of CAP (OR = 1.05, 95% CI, 0.67-1.64). Nemonoxacin also had a similar microbiologic response rate than levofloxacin (OR = 0.89, 95% CI, 0.44 to 1.81).…”

Section: Nemonoxacinmentioning

confidence: 99%