Pharmacokinetic evaluation of fluoroquinolone antibiotics administered intravenously in intensive care patients with normal renal function and with renal hyperfiltratio
Phase 1
- Conditions
- Intensive care patients
- Registration Number
- EUCTR2010-019691-70-BE
- Lead Sponsor
- Ghent University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patients hospitalized at the Department Intensive Care Unit who are being treated with Tavanic I.V. (500mg, twice daily) for an infection.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
• Younger than 18 years
• No informed consent
• No arterial catheter
• Hematocrite = 21
• Pregnancy and lactation
• Creatinine clearance < 80 ml/min
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To describe the pharmacokinetics of fluoroquinolone antibiotics intravenously administered in intensive care patients with renal hyperfiltration, in comparison with patients with normal renal function. ;Secondary Objective: ;Primary end point(s): Pharmacokinetics of levofloxacin: maximum plasma concentration (Cmax), area under the plasma concentration-time curve (AUC) and time to reach maximum plasma concentration (tmax)<br>
- Secondary Outcome Measures
Name Time Method