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

NCT ID: NCT01109823

Last Updated: 2021-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-19

Study Completion Date

2013-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

intravenous administration of levofloxacin

Intervention Type DRUG

Intravenous administration of levofloxacin is used.

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.

Group Type ACTIVE_COMPARATOR

intravenous administration of levofloxacin

Intervention Type DRUG

Intravenous administration of levofloxacin is used.

Interventions

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intravenous administration of levofloxacin

Intravenous administration of levofloxacin is used.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Van Bocxlaer, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

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University Ghent

Ghent, , Belgium

Site Status

University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2010/167

Identifier Type: -

Identifier Source: org_study_id

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