Pharmacokinetics of Levofloxacin in Intensive Care Unit

NCT ID: NCT02018081

Last Updated: 2015-03-05

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

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-09-30

Brief Summary

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The aim of this study is 1. to describe levofloxacin pharmacokinetics in ICU patients suffering from pneumonia with taking into account physio-pathological parameters. 2. to verify clinical and bacteriological efficiency and to know if the peak/Minimum Inhibitory Concentration (MIC) ratio \> 5 and Area Under Curve (AUC) /Minimum Inhibitory Concentration(MIC) ratio \> 125. No therapeutic drug monitoring will be performed in this study.

Detailed Description

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Conditions

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Intensive Care Unit Syndrome Community-acquired Pneumonia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Levofloxacin

Population having a community-acquired pneumonia of which the indication of the treatment is administration of Levofloxacin

Group Type EXPERIMENTAL

Levofloxacin

Intervention Type DRUG

8 blood sampling by patients between the 48th and 60th

Interventions

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Levofloxacin

8 blood sampling by patients between the 48th and 60th

Intervention Type DRUG

Other Intervention Names

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pharmacokinetic

Eligibility Criteria

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Inclusion Criteria

* severe community-acquired pneumonia due to a strain sensible to levofloxacin
* Age \> 18 years
* Informed consent
* SAPS II (simplified acute physiological score) \> 20 Awaited duration of survival higher than 7 days

Exclusion Criteria

* Historic of allergy to levofloxacin
* Resistant strain to levofloxacin
* Pregnancy
* Contra-indications of levofloxacin use, renal failure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bernard GEORGES, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Toulouse

Locations

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University Hospital Toulouse

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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10 150 02

Identifier Type: -

Identifier Source: org_study_id

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