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

Phase 3

Completed

• Conditions: Infection
• Interventions: Drug: intravenous administration of levofloxacin

• Registration Number: NCT01109823
• Lead Sponsor: University Ghent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-22
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-23
• Study Start: 2010-05-19
• Primary Completion: 2013-12-01
• Study Completion: 2013-12-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-23
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients with normal renal function	intravenous administration of levofloxacin	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.
patients with hyperfiltration	intravenous administration of levofloxacin	Patients with hyperfiltration hospitalized at the Department Intensive Care Unit who are being treated with levofloxacin I.V. (500mg, twice daily) for an infection.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

University Ghent; 🇧🇪 Ghent, Belgium

University Hospital Ghent; 🇧🇪 Ghent, Belgium