Community-acquired Pneumonia, Intensive Care Unit Syndrome
Conditions
Keywords
pharmacokinetic study : open, prospective, monocentric
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.
Interventions
DRUGLevofloxacin
8 blood sampling by patients between the 48th and 60th
Sponsors
University Hospital, Toulouse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Outcome results
None listed