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

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ClinicalTrials.gov Identifier: NCT00861315
Recruitment Status : Unknown
Verified March 2009 by Association Pour La Promotion A Tours De La Reanimation Medicale.
Recruitment status was:  Recruiting
First Posted : March 13, 2009
Last Update Posted : March 16, 2009
Sponsor:
Information provided by:
Association Pour La Promotion A Tours De La Reanimation Medicale

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

Condition or disease Intervention/treatment Phase
Ventilator Associated Pneumonia Drug: Nebulized amikacin Drug: Intravenous amikacin Drug: Placebo nebulization Drug: Placebo infusion Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Study of High Dose Nebulized Amikacin in Patients With Pneumonia Undergoing Mechanical Ventilation
Study Start Date : January 2009
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Comparison of clinical pulmonary infection score evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin [ Time Frame: 10 days ]
  2. Comparison of serum procalcitonin concentration evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin [ Time Frame: 10 days ]
  3. Comparison of c reactive protein evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin [ Time Frame: 10 days ]
  4. Comparison duration of mechanical ventilation between patients treated with nebulized amikacin and patients treated with intravenous amikacin [ Time Frame: 10 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00861315


Contacts
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Contact: Stephan Ehrmann, MD +33(0)671103302 stephanehrmann@gmail.com

Locations
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France
Service de réanimation médicale polyvalente. Hôpital Bretonneau CHRU Recruiting
Tours, Indre et Loire, France, F37044
Contact: Stephan Ehrmann, MD    +33(0)671103302    stephanehrmann@gmail.com   
Principal Investigator: Stephan Ehrmann, MD         
Sub-Investigator: Emmanuelle Mercier, MD         
Sub-Investigator: Pierre-François Dequin, MD, PhD         
Sub-Investigator: Denis Garot, MD         
Sub-Investigator: Annick Legras, MD         
Sub-Investigator: Dominique Perrotin, MD         
Service de réanimation médicale. Hôpital La Source. CH Orléans Recruiting
Orléans, Loiret, France, F45067
Contact: Thierry Boulain, MD    +33(0)238514446    thierry.boulain@chr-orleans.fr   
Principal Investigator: Thierry Boulain, MD         
Sponsors and Collaborators
Association Pour La Promotion A Tours De La Reanimation Medicale
More Information
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Responsible Party: Pr Dominique Perrotin, Association Pour La Promotion A Tours De La Reanimation Medicale
ClinicalTrials.gov Identifier: NCT00861315    
Other Study ID Numbers: DARTAGNAN
First Posted: March 13, 2009    Key Record Dates
Last Update Posted: March 16, 2009
Last Verified: March 2009
Keywords provided by Association Pour La Promotion A Tours De La Reanimation Medicale:
Pneumonia
Nebulization
Amikacin
Additional relevant MeSH terms:
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Pneumonia
Pneumonia, Ventilator-Associated
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Healthcare-Associated Pneumonia
 Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Amikacin
Anti-Bacterial Agents
Anti-Infective Agents