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
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|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|
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 (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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
- Comparison of clinical pulmonary infection score evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin [ Time Frame: 10 days ]
- Comparison of serum procalcitonin concentration evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin [ Time Frame: 10 days ]
- Comparison of c reactive protein evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin [ Time Frame: 10 days ]
- Comparison duration of mechanical ventilation between patients treated with nebulized amikacin and patients treated with intravenous amikacin [ Time Frame: 10 days ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients admitted to intensive care unit.
- Patients undergoing mechanical ventilation for more than 48H.
- Suspicion of ventilator associated pneumonia.
- 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.
- Brain death.
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
|Contact: Stephan Ehrmann, MD||+33(0)email@example.com|
|Service de réanimation médicale polyvalente. Hôpital Bretonneau CHRU||Recruiting|
|Tours, Indre et Loire, France, F37044|
|Contact: Stephan Ehrmann, MD +33(0)671103302 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Thierry Boulain, MD|
|Responsible Party:||Pr Dominique Perrotin, Association Pour La Promotion A Tours De La Reanimation Medicale|
|Other Study ID Numbers:||
|First Posted:||March 13, 2009 Key Record Dates|
|Last Update Posted:||March 16, 2009|
|Last Verified:||March 2009|
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