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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
- Source :
- Journal of Microbiology, Immunology and Infection, Vol 52, Iss 1, Pp 35-44 (2019)
- Publication Year :
- 2017
-
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
- Subjects :
- 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
Subjects
Details
- ISSN :
- 19959133
- Volume :
- 52
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Journal of microbiology, immunology, and infection = Wei mian yu gan ran za zhi
- Accession number :
- edsair.doi.dedup.....1e54aa2cb62fc36daf3a95922bdc4f64