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

University Ghent

Status and phase: Completed; Phase 3

Conditions: Infection

Treatments: Drug: intravenous administration of levofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT01109823

2010/167

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

patients with normal renal function

Active Comparator group

Description:

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.

Treatment:

Drug: intravenous administration of levofloxacin

patients with hyperfiltration

Active Comparator group

Description:

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

Treatment:

Drug: intravenous administration of levofloxacin