Pharmacokinetics of moxifloxacin in patients with severe sepsis or septic shock
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To investigate the steady-state pharmacokinetics of moxifloxacin in critically ill patients after intravenous administration of the 400 mg fixed dose.
Fifteen adult patients with severe sepsis (n = 3) or septic shock (n = 12) were enrolled in this dual-centre, prospective, open-label study. Moxifloxacin was administered with the recommended dose of 400 mg once daily i.v. for at least 5 days. Blood samples were obtained before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18 and 24 h after the third administration. Moxifloxacin concentrations in plasma were measured by HPLC with fluorescence detection.
Data for 400 mg moxifloxacin i.v. were as follows (geometric mean): C max: 3.5 mg/l, t ½: 7.8 h and AUC (48–72 h): 25 mg h/l. In five individual patients AUC (48–72 h) was <20 mg h/l.
The main pharmacokinetics/pharmacodynamics parameter predicting clinical efficacy of moxifloxacin is AUC/MIC. The mean AUC of patients with severe sepsis or septic shock was lower compared to healthy volunteers (39 mg h/l). In 5 of 12 patients the AUC was halved compared to healthy volunteers.
KeywordsClinical trial Intensive care Sepsis Human Moxifloxacin Pharmacokinetics
This study was supported the German Competence Network Sepsis (SepNet) funded by the Federal Ministry of Education and Research (BMBF, Grant no. 01 KI 0106) and by an unrestricted grant from Bayer Healthcare, Germany.