Pharmacokinetics of Levofloxacin in Intensive Care Unit

Overview

The aim of this study is 1. to describe levofloxacin pharmacokinetics in ICU patients suffering from pneumonia with taking into account physio-pathological parameters. 2. to verify clinical and bacteriological efficiency and to know if the peak/Minimum Inhibitory Concentration (MIC) ratio > 5 and Area Under Curve (AUC) /Minimum Inhibitory Concentration(MIC) ratio > 125. No therapeutic drug monitoring will be performed in this study.

Full Title of Study: “Population Pharmacokinetics of Levofloxacin in Intensive Care Patients With Severe Community-acquired Pneumonia.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2014

Interventions

  • Drug: Levofloxacin
    • 8 blood sampling by patients between the 48th and 60th

Arms, Groups and Cohorts

  • Experimental: Levofloxacin
    • Population having a community-acquired pneumonia of which the indication of the treatment is administration of Levofloxacin

Clinical Trial Outcome Measures

Primary Measures

  • Levofloxacin dosage regimen, time of administration and time of blood sampling, levofloxacin serum concentrations.
    • Time Frame: Levofloxacin concentration assessment at 8 different time points during 12h

Secondary Measures

  • Efficiency (clinical,bacteriological, pharmacodynamic)
    • Time Frame: 12 hours
    • age, weight, height, sex, SAPS II, blood urea nitrogen (BUN), creatinine, mechanical ventilation, leukocytes, haemoglobin, procalcitonin, creatinine clearance, proteins, MIC of the strain.

Participating in This Clinical Trial

Inclusion Criteria

  • severe community-acquired pneumonia due to a strain sensible to levofloxacin
  • Age > 18 years
  • Informed consent
  • SAPS II (simplified acute physiological score) > 20 Awaited duration of survival higher than 7 days

Exclusion Criteria

  • Historic of allergy to levofloxacin
  • Resistant strain to levofloxacin
  • Pregnancy
  • Contra-indications of levofloxacin use, renal failure

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Toulouse
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bernard GEORGES, MD, PhD, Principal Investigator, University Hospital of Toulouse

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