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

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.

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Key information

Conditions

Infection Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Ghent, Ghent, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intravenous administration of levofloxacin

Drug

Intravenous administration of levofloxacin is used.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Apr 23, 2010
Registry last updated: Jun 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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