Pharmacokinetics of Nebulized Amikacin in Non Invasive Ventilated Healthy Volunteers. (NIV-NEBU)
Primary Purpose
Acute Respiratory Insufficiency, Chronic Respiratory Insufficiency, Bronchospasm and Obstruction
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Nebulizer
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Insufficiency focused on measuring non invasive ventilation, single limb circuit ventilator, bilevel, nebulization, nebulizer, vibrating mesh nebulizer, amikacin
Eligibility Criteria
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
Sites / Locations
- Cliniques Universitaires Saint-Luc (Service des soins intensifs)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Solo nebulizer
Pro nebulizer
NIVO nebulizer
Arm Description
Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb Solo nebulizer associated with a bilevel ventilator
Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb Pro nebulizer associated with a bilevel ventilator
Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb NIVO nebulizer associated with a bilevel ventilator
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01901497
First Posted
July 2, 2013
Last Updated
January 29, 2016
Sponsor
University Hospital St Luc, Brussels
Collaborators
Haute Ecole de Santé Vaud, Université Catholique de Louvain, Ligue Pulmonaire Neuchâteloise
1. Study Identification
Unique Protocol Identification Number
NCT01901497
Brief Title
Pharmacokinetics of Nebulized Amikacin in Non Invasive Ventilated Healthy Volunteers.
Acronym
NIV-NEBU
Official Title
Comparison of Pharmacokinetics of Amikacin Administered by Three Vibrating Mesh Nebulizers in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital St Luc, Brussels
Collaborators
Haute Ecole de Santé Vaud, Université Catholique de Louvain, Ligue Pulmonaire Neuchâteloise
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Insufficiency, Chronic Respiratory Insufficiency, Bronchospasm and Obstruction
Keywords
non invasive ventilation, single limb circuit ventilator, bilevel, nebulization, nebulizer, vibrating mesh nebulizer, amikacin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Solo nebulizer
Arm Type
Experimental
Arm Description
Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb Solo nebulizer associated with a bilevel ventilator
Arm Title
Pro nebulizer
Arm Type
Experimental
Arm Description
Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb Pro nebulizer associated with a bilevel ventilator
Arm Title
NIVO nebulizer
Arm Type
Experimental
Arm Description
Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb NIVO nebulizer associated with a bilevel ventilator
Intervention Type
Device
Intervention Name(s)
Nebulizer
Other Intervention Name(s)
Vibrating-mesh nebulizers
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pharmacokinetics of nebulized amikacin
Description
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.
Time Frame
within the first 24 hours after nebulization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Bernard Michotte, PhD student
Organizational Affiliation
Cliniques Universitaires Saint-Luc (service de pneumologie), Haute Ecole de Santé Vaud (filière physiothérapie), Université Catholique de Louvain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emilie Jossen, BSc
Organizational Affiliation
Ligue Pulmonaire Neuchâteloise
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean Roeseler, PhD
Organizational Affiliation
Cliniques Universitaires Saint-Luc (service des soins intensifs)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Giuseppe Liistro, MD, PhD
Organizational Affiliation
Université Catholique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Pôle de Pneumologie, ORL & Dermatologie, 1200 Brussels, Belgium
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Grégory Reychler, PhD
Organizational Affiliation
Cliniques Universitaires Saint-Luc (service de pneumologie), Université Catholique de Louvain
Official's Role
Study Director
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc (Service des soins intensifs)
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics of Nebulized Amikacin in Non Invasive Ventilated Healthy Volunteers.
We'll reach out to this number within 24 hrs