Pharmacokinetics of Nebulized Amikacin in Non Invasive Ventilated Healthy Volunteers.

Not Applicable

Completed

• Conditions: Bronchospasm and Obstruction; Chronic Respiratory Insufficiency; Acute Respiratory Insufficiency
• Interventions: Device: Nebulizer

• Registration Number: NCT01901497
• Lead Sponsor: University Hospital St Luc, Brussels

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-02
• Study First Submitted QC: 2013-07-13
• Study First Posted: 2013-07-17
• Primary Completion: 2015-06
• Status Verified: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-29
• Last Update Posted: 2016-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pro nebulizer	Nebulizer	Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb Pro nebulizer associated with a bilevel ventilator
Solo nebulizer	Nebulizer	Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb Solo nebulizer associated with a bilevel ventilator
NIVO nebulizer	Nebulizer	Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb NIVO nebulizer associated with a bilevel ventilator

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of nebulized amikacin	within the first 24 hours after nebulization	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.

Trial Locations

Locations (1)

Cliniques Universitaires Saint-Luc (Service des soins intensifs); 🇧🇪 Brussels, Belgium