Pharmacokinetics of Levofloxacin in Intensive Care Unit

Phase 4

Completed

• Conditions: Intensive Care Unit Syndrome; Community-acquired Pneumonia
• Interventions: Drug: Levofloxacin

• Registration Number: NCT02018081
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-07-04
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-23
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Efficiency (clinical,bacteriological, pharmacodynamic)	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.

Trial Locations

Locations (1)

University Hospital Toulouse; 🇫🇷 Toulouse, France