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

This study has been completed.
Sponsor:
Collaborators:
Haute Ecole de Santé Vaud
Université Catholique de Louvain
Ligue pulmonaire neuchâteloise
Information provided by (Responsible Party):
Jean-Bernard Michotte, University Hospital St Luc, Brussels
ClinicalTrials.gov Identifier:
NCT01901497
First received: July 2, 2013
Last updated: January 29, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention
Acute Respiratory Insufficiency
Chronic Respiratory Insufficiency
Bronchospasm and Obstruction
Device: Nebulizer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Pharmacokinetics of Amikacin Administered by Three Vibrating Mesh Nebulizers in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by University Hospital St Luc, Brussels:

Primary Outcome Measures:
  • Pharmacokinetics of nebulized amikacin [ Time Frame: within the first 24 hours after nebulization ] [ Designated as safety issue: No ]
    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.


Enrollment: 7
Study Start Date: July 2013
Study Completion Date: January 2016
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Vibrating-mesh nebulizers

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01901497

Locations
Belgium
Cliniques Universitaires Saint-Luc (Service des soins intensifs)
Brussels, Belgium, 1200
Sponsors and Collaborators
University Hospital St Luc, Brussels
Haute Ecole de Santé Vaud
Université Catholique de Louvain
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
  More Information

Responsible Party: Jean-Bernard Michotte, MSc, PhD Student, University Hospital St Luc, Brussels
ClinicalTrials.gov Identifier: NCT01901497     History of Changes
Other Study ID Numbers: NIVnebu 
Study First Received: July 2, 2013
Last Updated: January 29, 2016
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital St Luc, Brussels:
non invasive ventilation
single limb circuit ventilator
bilevel
nebulization
nebulizer
vibrating mesh nebulizer
amikacin

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Bronchial Spasm
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Bronchial Diseases
Amikacin
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on December 02, 2016