Pharmacokinetics of Levofloxacin in Intensive Care Unit

Community-acquired Pneumonia Clinical Trial

— LEVO-PHARM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02018081
• Other study ID #: 10 150 02
• Status: Completed
• Phase: Phase 4
• First received: July 4, 2013
• Last updated: March 4, 2015
• Start date: March 2012
• Est. completion date: September 2014

Study information

• Verified date: March 2015
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Intensive Care Unit Syndrome
• Pneumonia

Intervention

Drug:
• Levofloxacin
8 blood sampling by patients between the 48th and 60th

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levofloxacin dosage regimen, time of administration and time of blood sampling, levofloxacin serum concentrations.		Levofloxacin concentration assessment at 8 different time points during 12h	Yes
Secondary	Efficiency (clinical,bacteriological, pharmacodynamic)	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	Yes