Pharmacokinetic and colimicine (ColistinaR) concentrations in broncho alveolar lavage in patients affected by pulmonary infections caused by Gram - bacteria. - ND
- Conditions
- pulmonary disease caused by Gram - infectionMedDRA version: 9.1Level: LLTClassification code 10061229Term: Lung infection
- Registration Number
- EUCTR2007-005045-38-IT
- Lead Sponsor
- OSPEDALE POLICLINICO S. MATTEO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
age > 18 years, patient with pulmonary infection, needing respiratory assistance, secretion containing Gram -
Are the trial subjects under 18? no
Number of subjects for this age range:
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
age < 18 years, patient with known sensibility to colimicine, pregnant woman
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate the colimicine (ColistinaR) pharmacokinetic, assessed by specific HPLC method, measuring plasma, urine and epitelial lining fluid (ELF)(obtained by broncho alveolar lavage) concentrations in patients affected by bacterical Gram - pneumonia.;Secondary Objective: not specified;Primary end point(s): to evaluate colimicine pharmacokinetic and pharmacodinamic parameters (in particular ELF concentration) in ventilated patient, with pulmonary infection in critical conditions
- Secondary Outcome Measures
Name Time Method