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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-000248-15-FR

Enrollment

Registered

2008-06-06

Start date

2008-08-01

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator associated pneumonia MedDRA version: 9.1 Level: LLT Classification code 10065153 Term: Ventilator associated pneumonia

Interventions

Trade Name: Amikacin Product Name: Amikacin nébulisée Product Code: Amikacin nébulisée Pharmaceutical Form: Nebuliser solution INN or Proposed INN: AMIKACIN Concentration unit: mg/kg milligram(s)/kilo

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. To evaluate de potential pulmonary and systemic accumulation of amikacin after repeated nebulizations. To evaluate the clinical benefit of nebulized amikacine compared to intravenous infusion of amikacin. To modelize pulmonary absorption kinetics of nebulized amikacin.	—

Measure

Time frame

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. To evaluate de potential pulmonary and systemic accumulation of amikacin after repeated nebulizations. To evaluate the clinical benefit of nebulized amikacine compared to intravenous infusion of amikacin. To modelize pulmonary absorption kinetics of nebulized amikacin.

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Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026