Clinical pharmacokinetics of ciprofloxacin in patients with major burns

Objective: To better master the use of ciprofloxacin (CPF) in burn patients , a clinical study, including pharmacokinetics in serum and urine, was unde rtaken in a pathophysiologically homogeneous population of major-burn subje cts. Methods: Twelve major-burn patients who were infected with Pseudomonas aeru ginosa, enterobacteria and grampositive 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 dos es; urine was collected during the first infusion. Levels of CPF in serum a nd urine were measured by means of high-performance liquid chromatography. A non-compartmental method was used for kinetic and graphic analysis of con centration-time pairs. Results: No adverse effects were noted. Trough concentrations measured on d ay 3 (mean +/- SD) were above the minimum inhibitory concentration (MIC) fo r the organism responsible for infection; i.e., 2.0 +/- 1.2 mu g.ml(-1) and maximum concentrations were high 9.9 +/- 3.4 mu g.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 wit h a MIC of 0.5 mu g.ml(-1). There was a statistically significant differenc e between C-min and AUC determined on day 1 and day 3. In contrast to healt hy 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.