Pharmacokinetics of Levofloxacin in Intensive Care Unit (LEVO-PHARM)

March 4, 2015 updated by: University Hospital, Toulouse

Population Pharmacokinetics of Levofloxacin in Intensive Care Patients With Severe Community-acquired Pneumonia.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • University Hospital Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levofloxacin
Population having a community-acquired pneumonia of which the indication of the treatment is administration of Levofloxacin
Drug: Levofloxacin
8 blood sampling by patients between the 48th and 60th
Other Names:
  • pharmacokinetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Levofloxacin dosage regimen, time of administration and time of blood sampling, levofloxacin serum concentrations.
Time Frame: Levofloxacin concentration assessment at 8 different time points during 12h
Levofloxacin concentration assessment at 8 different time points during 12h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficiency (clinical,bacteriological, pharmacodynamic)
Time Frame: 12 hours
age, weight, height, sex, SAPS II, blood urea nitrogen (BUN), creatinine, mechanical ventilation, leukocytes, haemoglobin, procalcitonin, creatinine clearance, proteins, MIC of the strain.
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Bernard GEORGES, MD, PhD, University Hospital of Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

July 4, 2013

First Submitted That Met QC Criteria

December 16, 2013

First Posted (Estimate)

December 23, 2013

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10 150 02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intensive Care Unit Syndrome

Clinical Trials on Levofloxacin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe