Pharmacokinetics of Nebulized Amikacin in Patients With Pneumonia Undergoing Mechanical Ventilation
Information source: Association Pour La Promotion A Tours De La Reanimation Medicale
ClinicalTrials.gov processed this data on August 20, 2015 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 amikacinComparison 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
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