Prulifloxacin versus Levofloxacin in the Treatment of Respiratory and Urinary Tract Infections: A Multicentre, Double-Blind, Randomized Controlled Clinical Trial

• Published in: Chemotherapy (Basel) Vol. 58; no. 3; pp. 249 - 256
• Main Authors: Chen, Yongchuan, Yang, Heping, Lu, Gensheng, Wu, Xiongfei, Huang, Wenxiang, Wu, Yamei, Lv, Xiaoju, Wu, Guoming, Zhang, Genfu, Li, Qiang, Sun, Yinghao
• Format: Journal Article
• Language: English
• Published: Basel, Switzerland S. Karger AG 01.01.2012
• Subjects: Adolescent; Adult; Aged; Anti-Bacterial Agents - therapeutic use; Antibiotics; Bacterial infections; Clinical Study; Dioxolanes - pharmacology; Dioxolanes - therapeutic use; Disk Diffusion Antimicrobial Tests; Double-Blind Method; Female; Fluoroquinolones - pharmacology; Fluoroquinolones - therapeutic use; Gram-Negative Bacteria - drug effects; Gram-Positive Bacteria - drug effects; Humans; Levofloxacin; Male; Middle Aged; Ofloxacin - pharmacology; Ofloxacin - therapeutic use; Piperazines - pharmacology; Piperazines - therapeutic use; Respiratory diseases; Respiratory Tract Infections - drug therapy; Treatment Outcome; Urinary tract diseases; Urinary Tract Infections - drug therapy; Young Adult; China; Bacterial infection; Levofloxacin; Prulifloxacin
• ISSN: 0009-3157; 1421-9794
• DOI: 10.1159/000339718

Background: Prulifloxacin is a promising fluoroquinolone antibiotic. A multicentre, double-blind, randomized clinical study was designed to evaluate its efficacy and safety compared to that of levofloxacin for the treatment of respiratory and urinary infections of Chinese patients. Methods: A total of 267 patients were enrolled and each was randomly assigned to either the treatment or the control group. Prulifloxacin 264.2 mg (equivalent to ulifloxacin 200 mg) b.i.d. or levofloxacin hydrochloride 200 mg b.i.d. was administered orally for 5–14 days according to a patient’s condition. The clinical response, bacterial eradication and incidence of adverse events were evaluated. Results: Two hundred and forty-three patients completed the study. For the modified intention-to-treat population, the cure and effective rates were 45.53 and 82.93% in the prulifloxacin group and 49.18 and 83.61% in the levofloxacin group. For the per-protocol analysis population, the cure and effective rates were 45.90 and 83.61% in the prulifloxacin group and 49.59 and 83.47% in the levofloxacin group. The bacterial eradication rates were 96.59 and 95.35%, and the drug-related adverse event rates were 7.87 and 5.51% in the prulifloxacin and levofloxacin group, respectively. The cure rate and efficacy rate of respiratory and urinary tract infections of the levofloxacin group were better than those of the prulifloxacin group. However, the difference between the 2 groups was not statistically significant (p > 0.05). Conclusion: Prulifloxacin is as effective and well tolerated as levofloxacin in the treatment of respiratory and urinary tract infections.