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Pharmacokinetics of Nebulized Amikacin in Patients With Pneumonia Undergoing Mechanical Ventilation

NCT00861315 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2009-03-16

No results posted yet for this study

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 amikacin to be nebulized in order to observe amikacin serum concentrations close to but inferior to those observed after standart intravenous amikacin infusion.

Conditions

  • Ventilator Associated Pneumonia

Interventions

DRUG

Nebulized amikacin

Amikacin is nebulized at a dose of 60 mg/Kg (6 first patients of the arm), 80 mg/Kg (6 subsequent patients) or 100 mg/Kg (last 6 patients of the arm)

DRUG

Intravenous amikacin

20 mg/Kg amikacin are administred intravenousely once a day during three days.

DRUG

Placebo nebulization

0.9% saline solution is nebulized once a day during three days

DRUG

Placebo infusion

0.9% saline is administered intravenousely once a day during three days

Sponsors & Collaborators

  • Association Pour La Promotion A Tours De La Reanimation Medicale

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00861315 on ClinicalTrials.gov