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

This study is currently recruiting participants.
Verified April 2012 by University Ghent
Sponsor:
Information provided by (Responsible Party):
University Ghent
ClinicalTrials.gov Identifier:
NCT01109823
First received: April 22, 2010
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Infection
 Drug: intravenous administration of levofloxacin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetic Evaluation of Fluoroquinolone Antibiotics Administered Intravenously in Intensive Care Patients With Normal Renal Function and With Renal Hyperfiltration

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by University Ghent:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: patients with normal renal function
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
Intravenous administration of levofloxacin is used.
Active Comparator: patients with hyperfiltration
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
Intravenous administration of levofloxacin is used.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109823

Contacts
Contact: Koen Boussery, Pharm, Dr koen.boussery@ugent.be

Locations
Belgium
University Ghent Recruiting
Ghent, Belgium
Principal Investigator: Jan Van Bocxlaer, PhD            
Sub-Investigator: Koen Boussery, Pharm, Dr            
University Hospital Ghent Recruiting
Ghent, Belgium
Contact: Jan De Waele, MD, PhD         jan.dewaele@ugent.be    
Principal Investigator: Jan De Waele, MD            
Sponsors and Collaborators
University Ghent
Investigators
Principal Investigator: Jan Van Bocxlaer, PhD University Ghent
  More Information

No publications provided

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01109823     History of Changes
Other Study ID Numbers: 2010/167
Study First Received: April 22, 2010
Last Updated: April 18, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board

Keywords provided by University Ghent:
Patients hospitalized at Intensive Care Unit treated with levofloxacin IV

Additional relevant MeSH terms:
Anti-Bacterial Agents
Ofloxacin
Fluoroquinolones
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on June 17, 2013