Pharmacokinetics of Nebulized Amikacin in Non Invasive Ventilated Healthy Volunteers. (NIV-NEBU)

Comparison of Pharmacokinetics of Amikacin Administered by Three Vibrating Mesh Nebulizers in Healthy Volunteers

The purpose of the study is to compare the pharmacokinetics of nebulized amikacin administered with three vibrating mesh nebulizers coupled with a single limb circuit bilevel ventilator in healthy volunteers. Following our previous in vitro study, our hypotheses are that the pharmacokinetics varies among the devices tested and that a most efficient device can be identified.

Study Overview

• Status: Completed
• Conditions: Chronic Respiratory Insufficiency; Acute Respiratory Insufficiency; Bronchospasm and Obstruction
• Intervention / Treatment: Device: Nebulizer

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc (Service des soins intensifs)

Participation Criteria

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:

• No contraindication of amikacin
• Written informed consent
• Negative pregnant test (for women)

Exclusion Criteria:

• History of respiratory disease
• History of renal disease
• History of otological disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Solo nebulizer; Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb Solo nebulizer associated with a bilevel ventilator	Device: Nebulizer; 500 mg/4 mL Amikacin nebulized using vibrating mesh nebulizer associated with a single limb bilevel ventilator. The nebulizations are considered as finished when there is no visible evidence of nebulization for a period of 30 seconds.; Other Names: Vibrating-mesh nebulizers
Experimental: Pro nebulizer; Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb Pro nebulizer associated with a bilevel ventilator	Device: Nebulizer; 500 mg/4 mL Amikacin nebulized using vibrating mesh nebulizer associated with a single limb bilevel ventilator. The nebulizations are considered as finished when there is no visible evidence of nebulization for a period of 30 seconds.; Other Names: Vibrating-mesh nebulizers
Experimental: NIVO nebulizer; Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb NIVO nebulizer associated with a bilevel ventilator	Device: Nebulizer; 500 mg/4 mL Amikacin nebulized using vibrating mesh nebulizer associated with a single limb bilevel ventilator. The nebulizations are considered as finished when there is no visible evidence of nebulization for a period of 30 seconds.; Other Names: Vibrating-mesh nebulizers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of nebulized amikacin	The area under the urinary amikacin concentration-time curve after nebulization(AUC0-24 hour) is calculated from the data obtained during 24 hours after nebulization. To determine amikacin absorption during the nebulization, amikacin concentrations are measured in the 24 hours urine collections, which reflected the quantity of dose absorbed via inhalation.	within the first 24 hours after nebulization

Collaborators and Investigators

• Sponsor: University Hospital St Luc, Brussels
• Collaborators: Université Catholique de Louvain; Haute Ecole de Santé Vaud; Ligue Pulmonaire Neuchâteloise
• Investigators: Principal Investigator: Jean-Bernard Michotte, PhD student, Cliniques Universitaires Saint-Luc (service de pneumologie), Haute Ecole de Santé Vaud (filière physiothérapie), Université Catholique de Louvain; Principal Investigator: Emilie Jossen, BSc, Ligue pulmonaire neuchâteloise; Study Chair: Jean Roeseler, PhD, Cliniques Universitaires Saint-Luc (Service des soins intensifs); Study Chair: Giuseppe Liistro, MD, PhD, Université Catholique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Pôle de Pneumologie, ORL & Dermatologie, 1200 Brussels, Belgium; Study Director: Grégory Reychler, PhD, Cliniques Universitaires Saint-Luc (service de pneumologie), Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: July 2, 2013
• First Submitted That Met QC Criteria: July 13, 2013
• First Posted (Estimate): July 17, 2013

Study Record Updates

• Last Update Posted (Estimate): February 1, 2016
• Last Update Submitted That Met QC Criteria: January 29, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: non invasive ventilation; nebulizer; nebulization; amikacin; single limb circuit ventilator; bilevel; vibrating mesh nebulizer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Bronchial Diseases; Respiratory Insufficiency; Bronchial Spasm
• Other Study ID Numbers: NIVnebu