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Pharmacokinetics of Nebulized Amikacin in Patients With Pneumonia Undergoing Mechanical Ventilation

Information source: Association Pour La Promotion A Tours De La Reanimation Medicale
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ventilator Associated Pneumonia

Intervention: Nebulized amikacin (Drug); Intravenous amikacin (Drug); Placebo nebulization (Drug); Placebo infusion (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Association Pour La Promotion A Tours De La Reanimation Medicale

Overall contact:
Stephan Ehrmann, MD, Phone: +33(0)671103302, Email: stephanehrmann@gmail.com

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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:

Comparison of clinical pulmonary infection score evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin

Comparison of serum procalcitonin concentration evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin

Comparison of c reactive protein evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin

Comparison duration of mechanical ventilation between patients treated with nebulized amikacin and patients treated with intravenous amikacin

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

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

Service de réanimation médicale polyvalente. Hôpital Bretonneau CHRU, Tours, Indre et Loire F37044, France; Recruiting
Stephan Ehrmann, MD, Phone: +33(0)671103302, Email: stephanehrmann@gmail.com
Stephan Ehrmann, MD, Principal 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, Sub-Investigator

Service de réanimation médicale. Hôpital La Source. CH Orléans, Orléans, Loiret F45067, France; Recruiting
Thierry Boulain, MD, Phone: +33(0)238514446, Email: thierry.boulain@chr-orleans.fr
Thierry Boulain, MD, Principal Investigator

Additional Information

Starting date: January 2009
Last updated: March 13, 2009

Page last updated: December 08, 2011

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