Status:

UNKNOWN

Pharmacokinetics of Nebulized Amikacin in Patients With Pneumonia Undergoing Mechanical Ventilation

Lead Sponsor:

Association Pour La Promotion A Tours De La Reanimation Medicale

Conditions:

Ventilator Associated Pneumonia

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

Brief Summary

Inclusion of patients undergoing mechanical ventilation and presenting a pneumonia in order to determine serum pharmacokinetics of nebulized amikacin. The primary aim is to determine the dose of amika...

Detailed Description

After inclusion, patients undergo intravenous infusion of 20 mg/Kg of amikacin with amikacin serum concentrations being monitored over the following 24 hours. Randomization occures after this first a...

Eligibility Criteria

Inclusion

  • Patients admitted to intensive care unit.
  • Patients undergoing mechanical ventilation for more than 48H.
  • Suspicion of ventilator associated pneumonia.

Exclusion

  • Allergy to amikacin or any compound of the medication.
  • Body mass index \> 30 kg/m2.
  • Myasthenia gravis.
  • Acute or chronic renal failure.
  • Vestibulo-cochlear disease.
  • Pregnancy.
  • Brain death.

Key Trial Info

Start Date :

January 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2011

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT00861315

Start Date

January 1 2009

End Date

January 1 2011

Last Update

March 16 2009

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Service de réanimation médicale polyvalente. Hôpital Bretonneau CHRU

Tours, Indre et Loire, France, F37044

2

Service de réanimation médicale. Hôpital La Source. CH Orléans

Orléans, Loiret, France, F45067