Pharmacokinetic evaluation of fluoroquinolone antibiotics administered intravenously in intensive care patients with normal renal function and with renal hyperfiltration

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019691-70-BE

Enrollment

Unknown

Registered

2010-04-07

Start date

2010-04-22

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive care patients

Interventions

Trade Name: Tavanic Product Name: levofloxacin Pharmaceutical Form: Solution for infusion INN or Proposed INN: LEVOFLOXACIN CAS Number: 100986854 Concentration unit: mg milligram(s) Concentration type

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: • Younger than 18 years • No informed consent • No arterial catheter • Hematocrite = 21 • Pregnancy and lactation • Creatinine clearance < 80 ml/min

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026