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

Study Overview
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Brief Summary
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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.

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

Conditions
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Infection

Intervention / Treatment
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* Drug: intravenous administration of levofloxacin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: patients with normal renal function<br>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. | Drug: intravenous administration of levofloxacin<br>* Intravenous administration of levofloxacin is used.<br>|
| Active Comparator: patients with hyperfiltration<br>Patients with hyperfiltration hospitalized at the Department Intensive Care Unit who are being treated with levofloxacin I.V. (500mg, twice daily) for an infection. | Drug: intravenous administration of levofloxacin<br>* Intravenous administration of levofloxacin is used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the pharmacokinetics of levofloxacin in patients with hyperfiltration, in comparison with critically ill patients with normal renal function. |  | 12 hours after start antibiotic treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients hospitalized at Intensive Care Unit treated with levofloxacin IV