Pharmacokinetic Evaluation of Fluoroquinolone Antibiotics Administered Intravenously in Intensive Care Patients With Normal Renal Function and With Renal Hyperfiltration
1 other identifier
interventional
14
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2010
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2010
CompletedFirst Posted
Study publicly available on registry
April 23, 2010
CompletedStudy Start
First participant enrolled
May 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJune 29, 2021
June 1, 2021
3.5 years
April 22, 2010
June 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
patients with normal renal function
ACTIVE COMPARATORPatients 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.
patients with hyperfiltration
ACTIVE COMPARATORPatients with hyperfiltration hospitalized at the Department Intensive Care Unit who are being treated with levofloxacin I.V. (500mg, twice daily) for an infection.
Interventions
Intravenous administration of levofloxacin is used.
Eligibility Criteria
You may qualify if:
- Patients hospitalized at the Department Intensive Care Unit who are being treated with levofloxacin I.V. (500mg, twice daily) for an infection.
You may not qualify if:
- Younger than 18 years
- No informed consent
- No arterial catheter
- Hematocrit ≤ 21
- Pregnancy and lactation
- Creatinine clearance \< 80 ml/min
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Ghentlead
Study Sites (2)
University Ghent
Ghent, Belgium
University Hospital Ghent
Ghent, Belgium
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Van Bocxlaer, PhD
University Ghent
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2010
First Posted
April 23, 2010
Study Start
May 19, 2010
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
June 29, 2021
Record last verified: 2021-06