Pharmacokinetics of Nebulized Amikacin in Patients With Pneumonia Undergoing Mechanical Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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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 amikacin infusion. Patients are randomized to group nebulized amikacin or intravenous amikacin. The three next days of the study patients recieve nebulized amikacin (or nebulized placebo) during mechanical ventilation and a placebo infusion (amikacin infusion in case of placebo nebulization) using a air driven jet nebulizer. Amikacin serum concentrations are monitored over 24 hours after each nebulization.

Patients are followed up during 10 days for safety and efficacy. The dose of amikacin to be nebulized is 60 mg/Kg for the first 6 patients (phase A), 80 mg/Kg for the next 6 patients (phase B) and 100 mg/Kg for the last 6 patients (phase C). Each phase is started after review of the results of the preceeding phase by an idependent safety and monitoring board.

Conditions

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Ventilator Associated Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nebulized amikacin

Patients receive nebulized amikacin once a day during three days. Placebo is administered intravenousely

Group Type EXPERIMENTAL

Nebulized amikacin

Intervention Type DRUG

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)

Placebo infusion

Intervention Type DRUG

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

Intravenous amikacin

Group Type ACTIVE_COMPARATOR

Intravenous amikacin

Intervention Type DRUG

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

Placebo nebulization

Intervention Type DRUG

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

Interventions

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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)

Intervention Type DRUG

Intravenous amikacin

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

Intervention Type DRUG

Placebo nebulization

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

Intervention Type DRUG

Placebo infusion

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No