A multicenter, single-blind, randomized comparison of sequential therapy of gatifloxacin versus levofloxacin in the treatment of bacterial infections

Objective: To evaluate the efficacy and safety of injectable gatifloxacin. Methods; In this multicenter, single-blind, randomized comparative study, patients with infection of lower respiratory tract and urinary tract were allocated randomly to gatifloxacin group or levofloxacin group. In each group patients were given gatifloxacin or levofloxacin intrevenously for 3-5 d followed by oral formulation. Results: (1)The clinical effective rates (gatifloxacin vs. levofloxacin) were 92.4%(110/119) vs. 91.2%(114/ 125), being 94.296(65/69) vs. 90.296(65/72) for lower respiratory tract infections and 90.0% (45/50) vs. 92.5%(42/72) for urinary tract infections, respectively, there was no statistically significant difference between the two groups; (2)The total bacterial eradication rates were 94.0% (78/83) vs. 88.0% (81/92), being 89.2% (33/37) vs. 92.9% (39/42) for urinary tract infections, there was no statistically significant difference between the two groups; however, the bacterial eradication rate of gatifloxacin (97.8% , 45/46) was higher than that of levofloxacin (84. 3% , 43/51) in lower respiratory tract infections, the difference was statistically significant. (3)Drug-related adverse effects were 29.9% (38/127) in gatifloxacin group, higher than that in levofloxacin group 10.1% (13/129). This is due to more patients with phlebitis and gastrointestinal symptoms in gatifloxacin group than those in levofloxacin group. These drug-related events could be alleviated by slowing down the speed of infusion; the adverse effects of both groups were mild and tolerable, no discontinuation of treatment due to adverse reaction. Drug-related abnormal laboratory findings oc- carred in gatifloxacin group and levefloxacin group were 24. 8% (30 /121) and 22. 1 % (27 /112) respectively. All were mild and transient, and there was no statistically significant difference between the two groups. Conclusions: Gatifloxacin given intravenously used as initial therapy in infectious patients with systemic clinical manifestations and followed by oral administration for the completion of therapy may get satisfactory results. The clinical efficacy of gatifloxacin is as good as that of levofloxacin. The adverse reaction rate of gatifloxacin was slightly higher than that of levofloxacin, but all the reactions are mild and tolerable.