Evaluation of the dosing regimens demonstrated similar AUC values across the different renal function groups.
For all renal dosing strata, >90% of the simulated subjects achieved an AUC(τ)/MIC ratio of ≥ 219 for MIC values as high as 2 mg/liter. For patients with CL(CR)s of <30 ml/min, the probability of target attainment (PTA) exceeded 90% for both the AUC₀₋₂₄ (AUC from 0 to 24 h) and AUC₂₄₋₄₈ intervals for MICs of ≤ 1 mg/liter. At a MIC of 2 mg/liter, the PTAs were 89.3% and 23.6% for the AUC₀₋₂₄ and AUC₂₄₋₄₈ intervals, respectively.
The comparable PTA profiles for the three dosing regimens across their respective dosing intervals indicate that the dose adjustments employed in phase III trials for complicated skin and skin structure infections were appropriate.