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Completed

NCT Number: NCT02018081

Pharmacokinetics of Levofloxacin in Intensive Care Unit

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.

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Key information

Conditions

Intensive Care Unit Syndrome Community-Acquired Infections Community-Acquired Pneumonia Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Toulouse

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levofloxacin

Drug

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

Other names: pharmacokinetic

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: LEVO-PHARM

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 23, 2013
Registry last updated
Mar 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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