Amikacine nébulisée à forte dose. Pharmacocinétique dans la pneumonie associée à la ventilation mécaniqueD’ARTAGNAN 3 - Dartagnan3

• Conditions: Ventilator associated pneumonia; MedDRA version: 9.1Level: LLTClassification code 10065153Term: Ventilator associated pneumonia

• Registration Number: EUCTR2008-000248-15-FR
• Lead Sponsor: Association pour la promotion de la réanimation médicale à Tours

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Patients hospitalized in the intensive care unit and undergoing mechanical ventilation for more than 48h and presenting a clinical, radiological and biological sucpicion of ventilator associated pneumonia.
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

Allergy to amikacin or any component of the IMPs
Acute or chronic kidney failure.
Myasthenia gravis.
Vestibulo-cochlear disorders.
Pregnancy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the maximal dosage of nebulized amikacin one may administer to patients undergoing mechanical ventilation in the intensive care unit and suffering of ventilator associated pneumonia without exceeding the amikacin serum concentrations measured after standard intravenous infusion of amikacin;Primary end point(s): Dose of nebulized amikacin that allows to measure serum amikacin concentrations close to but inferior to those measured after standard intravenous amikacin infusion. ;Secondary Objective: To evaluate safty of nebulized amikacin in intensive care unit patients. <br>To evaluate de potential pulmonary and systemic accumulation of amikacin after repeated nebulizations. <br>To evaluate the clinical benefit of nebulized amikacine compared to intravenous infusion of amikacin. <br>To modelize pulmonary absorption kinetics of nebulized amikacin.