Pharmacokinetic Evaluation of Fluoroquinolone Antibiotics Administered Intravenously in Intensive Care Patients With Normal Renal Function and With Renal Hyperfiltration

Overview

At the intensive care unit (ICU) fluoroquinolone antibiotics, like levofloxacin, are frequently used for the treatment of infections. Adequate blood levels are required for a good efficacy of the antibiotic. Due to the fact that levofloxacin is almost completely eliminated renally, the blood levels for this antibiotic are strongly influenced by the renal function. Therefore, this study aims to evaluate the pharmacokinetics of levofloxacin in patients with hyperfiltration, in comparison with critically ill patients with normal renal function.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1, 2013

Interventions

  • Drug: intravenous administration of levofloxacin
    • Intravenous administration of levofloxacin is used.

Arms, Groups and Cohorts

  • Active Comparator: patients with normal renal function
    • Patients with normal renal function hospitalized at the Department Intensive Care Unit who are being treated with levofloxacin I.V. (500mg, twice daily) for an infection.
  • Active Comparator: patients with hyperfiltration
    • Patients with hyperfiltration hospitalized at the Department Intensive Care Unit who are being treated with levofloxacin I.V. (500mg, twice daily) for an infection.

Clinical Trial Outcome Measures

Primary Measures

  • to evaluate the pharmacokinetics of levofloxacin in patients with hyperfiltration, in comparison with critically ill patients with normal renal function.
    • Time Frame: 12 hours after start antibiotic treatment

Participating in This Clinical Trial

Inclusion Criteria

  • Patients hospitalized at the Department Intensive Care Unit who are being treated with levofloxacin I.V. (500mg, twice daily) for an infection. Exclusion Criteria:

  • Younger than 18 years – No informed consent – No arterial catheter – Hematocrit ≤ 21 – Pregnancy and lactation – Creatinine clearance < 80 ml/min

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Ghent
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jan Van Bocxlaer, PhD, Principal Investigator, University Ghent

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