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

Abstract

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.

Emerging Treatment Options for Infections by Multidrug-Resistant Gram-Positive Microorganisms

“…A multi-centre, double-blind, randomised controlled phase III trial (NCT01529476) was conducted to assess the efficacy and safety of oral nemonoxacin compared with levofloxacin, which is the current recommendation for the treatment of CAP in adult patients [81]. Nemonoxacin was found to have a microbiological success rate that was not inferior to that of levofloxacin (92.1% vs 91.7%) for S. pneumoniae and S. aureus as well as good efficacy against atypical CAP pathogens, Mycoplasma pneumoniae, Chlamydophilia pneumoniae and Legionella pneumophila [81]. The common adverse drug reactions include nausea (3.4%), dizziness (2.8%), abdominal discomfort (2.2%) and vomiting (1.7%).…”

“…The common adverse drug reactions include nausea (3.4%), dizziness (2.8%), abdominal discomfort (2.2%) and vomiting (1.7%). Laboratories have found abnormalities including elevated alanine aminotransferase (5.9%), aspartate aminotransferase (2.5%), and leukopenia (2%) [81]. The drug-related clinical adverse events were mainly ALT elevation, decreased white blood cell (WBC) count and nausea, all of which were mild to moderate severity [81].…”

“…Laboratories have found abnormalities including elevated alanine aminotransferase (5.9%), aspartate aminotransferase (2.5%), and leukopenia (2%) [81]. The drug-related clinical adverse events were mainly ALT elevation, decreased white blood cell (WBC) count and nausea, all of which were mild to moderate severity [81]. Overall, nemonoxacin was found to be as effective and safe as levofloxacin in terms of clinical cure rates, and safety profile, making it a suitable alternative to fluoroquinolones for treating adult CAP patients [81].…”

“…The drug-related clinical adverse events were mainly ALT elevation, decreased white blood cell (WBC) count and nausea, all of which were mild to moderate severity [81]. Overall, nemonoxacin was found to be as effective and safe as levofloxacin in terms of clinical cure rates, and safety profile, making it a suitable alternative to fluoroquinolones for treating adult CAP patients [81]. In a phase II trial assessing the safety and efficacy of nemonoxacin in patients with diabetic foot infections (NCT00685698), some serious adverse events were noted, such as gangrene, abscess limb, osteomyelitis and increased blood glucose and blood pressure [82].…”

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

“…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.…”