Clinical evaluation of injectable gatifloxacin in the treatment of acute bacterial infections

Objective: To evaluate the clinical safety and efficacy of gatifloxacin in the treatment of acute bacterial infections. Methods: Two hundred and nine patients with lower respiratoy tract infection or urinary tract infection were enrolled into a randomized controlled multicenter clinical trial,and 400 mg gatifloxacin was given to each of 102 patients and 400mg levofloxacin as control to each of the other 107 by intravenous drip once a day for 7 to 14 days. Results: In gatifloxacin group 102 patients were assessable for safety and 101 for efficacy. In levofloxacin group,107 were assessable for safety and 106 for efficacy. The following were the results of gatifloxacin and levofloxacin groups: the clinical cure rate for lower respiratory tract infection,73.1% and 71.7%; efficacy rate for lower respiratory tract infection,90.4% and 92.5%; clinical cure rate for urinary tract infection,83.7% and 77.4%; efficacy rate for urinary tract infection,98.1% and 98.1%; total clinical cure rate,78.2% and 74.5%; total efficacy rate,94.1% and 95.3%; bacterial clearance rate,98.9% and 100%; and adverse occurance rate,3.9% and 10.3%. All above indicators had no significant difference between the two groups (P0.05). Conclusion: Gatifloxacin is effective and safe in the treatment of acute bacterial infection of respiratory and urinary tracts.