Abstract
This pilot study was undertaken to characterise the pharmacokinetics, pharmacodynamics and potential clinical efficacy of levofloxacin 750 mg once daily for 5 days for treatment of women with acute uncomplicated pyelonephritis. Four women diagnosed with acute pyelonephritis were enrolled. Following pre-therapy specimen collection, an initial oral dose of 750 mg levofloxacin was administered. The mean pharmacokinetic parameters for the first dose were: maximum serum concentration ( C max) 12.5 ± 4.7 mg/L (range 5.6–16.0 mg/L) ( fC max 8.8 ± 3.3, where f indicates the levofloxacin free or non-protein-bound fraction), area under the serum concentration–time curve (AUC) 85.4 ± 14.1 mg h/L (range 66.2–96.8 mg h/L) ( fAUC 59.8 ± 9.9) and serum half-life ( t 1/2) 6.7 ± 0.5 h. Mean urine concentrations were 88.0 ± 100 mg/L at the 0–3 h collection, 307 ± 143 mg/L at 3–6 h, 170 ± 107 mg/L at 6–12 h and 85 ± 8 mg/L at 12–24 h. Mean levofloxacin serum pharmacodynamics for infecting Escherichia coli were: C max/minimum inhibitory concentration (MIC) 323 ± 185 ( fC max/MIC 226 ± 129); and AUC/MIC 2339 ± 830 ( fAUC/MIC 1647 ± 579). Mean urine levofloxacin concentration/MIC ratios were: 900 ± 1389 for 0–3 h, 12 100 ± 4950 for 3–6 h, 5922 ± 3912 for 6–12 h and 2233 ± 1037 for 12–24 h. Levofloxacin eradicated E. coli from the urine by 3–6 h after the first dose. Levofloxacin 750 mg once daily for 5 days has pharmacodynamics that support further evaluation of this regimen for treatment of women with acute uncomplicated pyelonephritis.
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