Abstract
Objective: To better master the use of ciprofloxacin (CPF) in burn patients, a clinical study, including pharmacokinetics in serum and urine, was undertaken in a pathophysiologically homogeneous population of major-burn subjects.
Methods: Twelve major-burn patients who were infected with Pseudomonas aeruginosa, enterobacteria and gram-positive cocci, received CPF (600 mg t.i.d.). The mean body surface area affected by third-degree burns was 31.8 ± 14.5%. Two series of blood samples were drawn after the first and seventh doses; urine was collected during the first infusion. Levels of CPF in serum and urine were measured by means of high-performance liquid chromatography. A non-compartmental method was used for kinetic and graphic analysis of concentration–time pairs.
Results: No adverse effects were noted. Trough concentrations measured on day 3 (mean ± SD) were above the minimum inhibitory concentration (MIC) for the organism responsible for infection; i.e., 2.0 ± 1.2 μg · ml−1, and maximum concentrations were high 9.9 ± 3.4 μg · ml−1. An area under the concentration–time curve (AUC)/MIC ratio above 125 SIT−1 (where SIT is the serum inhibitory titer), which has been strongly correlated with clinical response and time to bacterial eradication, was achieved in 11 patients with a MIC of 0.5 μg · ml−1. There was a statistically significant difference between Cmin and AUC determined on day 1 and day 3. In contrast to healthy volunteers, CPF clearance rates were notably decreased.
Conclusion: The pharmacokinetics of CPF was altered in major-burn patients. The recommended dosage regimen for administration of CPF, i.e. 600 mg t.i.d. shows no adverse effects and a good microbiological efficacy.
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Received: 13 October 1998 / Accepted in revised form: 8 June 1999
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Lesne-Hulin, A., Bourget, P., Ravat, F. et al. Clinical pharmacokinetics of ciprofloxacin in patients with major burns. E J Clin Pharmacol 55, 515–519 (1999). https://doi.org/10.1007/s002280050666
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DOI: https://doi.org/10.1007/s002280050666