Pharmacokinetic and colimicine (ColistinaR) concentrations in broncho alveolar lavage in patients affected by pulmonary infections caused by Gram - bacteria.

INTERVENTION: Trade Name: COLIMICINA Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Colistin Concentration unit: U unit(s) Concentration type: equal Concentration number: 1000000‐ CONDITION: pulmonary disease caused by Gram ‐ infection ; MedDRA version: 9.1 Level: LLT Classification code 10061229 Term: Lung infection PRIMARY OUTCOME: 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. 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 Objective: 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