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

Toulouse University Hospital

Status and phase: Completed; Phase 4

Conditions: Community-acquired Pneumonia; Intensive Care Unit Syndrome

Treatments: Drug: Levofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT02018081

10 150 02

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Levofloxacin

Experimental group

Description:

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

Treatment:

Drug: Levofloxacin