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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109823
• Other study ID #: 2010/167
• Status: Completed
• Phase: Phase 3
• Start date: May 19, 2010
• Est. completion date: December 1, 2013

Study information

• Verified date: June 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 1, 2013
• Est. primary completion date: December 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection

Intervention

Drug:
• intravenous administration of levofloxacin
Intravenous administration of levofloxacin is used.

Locations

Country	Name	City	State
Belgium	University Ghent	Ghent
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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