A multicenter double blind double dummy randomized controlled clinical study of prulifloxacin versus levofloxacin in the treatment of acute bacterial infections

Objective: To evaluate the clinical efficacy and safety of prulifloxacin for the treatment of slight and moderate acute bacterial infections. Methods: A multicenter double blind double dummy randomized controlled clinical study was conducted to compare the efficacy and safety of prulifloxacin and levofloxacin. Both groups were administered at the dose of 200mg twice daily for 7 to 10 days. Results: Two hundred and seventy eight patients were enrolled in the study, 139 in each groups. Due to some unexpected events, finally, there were only 130 cases in prulifloxacin group and 126 cases in levofloxacin group were assessable for clinical efficacy by full analysis set (FAS), 123 cases in prulifloxacin group and 119 cases in levofloxacin group were assessable for clinical efficacy by per-protocol set (PPS) analysis. At the end of the treatment, in FAS analysis the total cure rats and effective rates were 53.85% and 86.92% in prulifloxacin group, 65.04% and 91.06% in levofloxacin group; in PPS analysis the total cure rates and effective rates were 55.56% and 89.68% in prulifloxacin group, 67.23% and 94.12% in levofloxacin group. The bacterial resistance rates were 90.43% and 87.10% respectively. There were no statistically significant differences between the two groups. Adverse reactions were observed in 5.15% and 6.57% of patients in the two groups, mainly nausea, diarrhea and elevated transaminases. No serious adverse event was reported in any group. Conclusions: Prulifloxacin is as effective and safe as levofloxacin in the treatment of slight and moderate acute bacterial infections.