Pharmacokinetics of Nebulized Amikacin in Non Invasive Ventilated Healthy Volunteers.

Acute Respiratory Insufficiency Clinical Trial

— NIV-NEBU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901497
• Other study ID #: NIVnebu
• Status: Completed
• Phase: N/A
• First received: July 2, 2013
• Last updated: January 29, 2016
• Start date: July 2013
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: University Hospital St Luc, Brussels
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Respiratory Insufficiency
• Bronchial Spasm
• Bronchospasm and Obstruction
• Chronic Respiratory Insufficiency
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc (Service des soins intensifs)	Brussels

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital St Luc, Brussels	Haute Ecole de Santé Vaud, Ligue pulmonaire neuchâteloise, Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No