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

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ClinicalTrials.gov Identifier: NCT01109823
Recruitment Status : Unknown
Verified December 2014 by University Ghent.
Recruitment status was:  Recruiting
First Posted : April 23, 2010
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Infection Drug: intravenous administration of levofloxacin Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2010
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01109823     History of Changes
Other Study ID Numbers: 2010/167
First Posted: April 23, 2010    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

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

Additional relevant MeSH terms:
Anti-Bacterial Agents
Levofloxacin
Ofloxacin
Fluoroquinolones
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors