Pharmacokinetics of Nebulized Amikacin in Patients With Pneumonia Undergoing Mechanical Ventilation (DARTAGNAN)

March 13, 2009 updated by: Association Pour La Promotion A Tours De La Reanimation Medicale

Phase II Study of High Dose Nebulized Amikacin in Patients With Pneumonia Undergoing Mechanical Ventilation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Indre et Loire
      • Tours, Indre et Loire, France, F37044
        • Recruiting
        • Service de réanimation médicale polyvalente. Hôpital Bretonneau CHRU
        • Sub-Investigator:
          • Denis Garot, MD
        • Sub-Investigator:
          • Emmanuelle Mercier, MD
        • Contact:
        • Principal Investigator:
          • Stephan Ehrmann, MD
        • Sub-Investigator:
          • Pierre-François Dequin, MD, PhD
        • Sub-Investigator:
          • Annick Legras, MD
        • Sub-Investigator:
          • Dominique Perrotin, MD
    • Loiret
      • Orléans, Loiret, France, F45067
        • Recruiting
        • Service de réanimation médicale. Hôpital La Source. CH Orléans
        • Principal Investigator:
          • Thierry Boulain, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nebulized amikacin
Patients receive nebulized amikacin once a day during three days. Placebo is administered intravenousely
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: Placebo infusion
0.9% saline is administered intravenousely once a day during three days
Active Comparator: Intravenous amikacin
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Determintion of nebulized amikacin dose (60 mg/Kg, 80 mg/Kg or 100 mg/Kg) which results in serum amikacin concentrations equal or below the serum amikacin concentrations measured after 20 mg/Kg intravenous amikacin infusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of clinical pulmonary infection score evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin
Time Frame: 10 days
10 days
Comparison of serum procalcitonin concentration evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin
Time Frame: 10 days
10 days
Comparison of c reactive protein evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin
Time Frame: 10 days
10 days
Comparison duration of mechanical ventilation between patients treated with nebulized amikacin and patients treated with intravenous amikacin
Time Frame: 10 days
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Pour La Promotion A Tours De La Reanimation Medicale

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

January 1, 2011

Study Completion (Anticipated)

January 1, 2011

Study Registration Dates

First Submitted

March 12, 2009

First Submitted That Met QC Criteria

March 12, 2009

First Posted (Estimate)

March 13, 2009

Study Record Updates

Last Update Posted (Estimate)

March 16, 2009

Last Update Submitted That Met QC Criteria

March 13, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DARTAGNAN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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