Interpretive criteria for disk diffusion susceptibility testing of ulifloxacin, the active metabolite of prulifloxacin.

Prulifloxacin, a new fluoroquinolone, is a prodrug whose active compound, ulifloxacin, is derived from its transformation after oral administration and intestinal absorption. Based on early pharmacokinetic and pharmacodynamic data, the following MIC breakpoints have tentatively been proposed: < or = 1 microg/ml, susceptible; 2 microg/ml, intermediate; and > or = 4 microg/ml, resistant. In this report, ulifloxacin MIC vs. zone diameter scattergrams and discrepancy rates were analyzed in 461 freshly isolated clinical strains (237 Enterobacteriaceae, 101 nonfermenters, and 123 Gram-positive bacteria). In agreement with the guidelines of the National Committee for Clinical Laboratory Standards, a modification of the error rate-bounded method was used to select disk diffusion test breakpoints. The following zone diameter breakpoints were chosen and are proposed herein for the interpretation of ulifloxacin disk (5 microg) test results: < or = 15 and > or = 19 mm for Enterobacteriaceae, < or = 16 and > or = 20 mm for nonfermenters, and < or = 14 and > or = 18 mm for Gram-positive bacteria. By applying these breakpoint values, no very major errors were detected, while major and minor errors were largely below the accepted discrepancy rates.