Population pharmacokinetics of levofloxacin in intensive care patients with severe community-acquired pneumonia - Lévo-Pharm
Phase 1
- Conditions
- community-acquired pneumoniaMedDRA version: 14.0 Level: LLT Classification code 10032502 Term: Other specified alveolar and parietoalveolar pneumopathies System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2011-002177-34-FR
- Lead Sponsor
- CHU de Toulouse
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 65
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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Historia of allergy to levofloxacin
Resistant strain to levofloxacin
Pregnancy
Contra-indications of levofloxacin use, renal failure
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of this study is to describe levofloxacin pharmacokinetics in ICU patients suffering from pneumonia with taking into account physio-pathological parameters;Secondary Objective: to verify clinical and bacteriological efficiency and to know if the peak/MIC ratio > 5 and AUC/MIC ratio > 125;Primary end point(s):
- Secondary Outcome Measures
Name Time Method