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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01901497
First Posted: July 17, 2013
Last Update Posted: February 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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 Jean-Bernard Michotte, University Hospital St Luc, Brussels:

Primary Outcome Measures:
  • Pharmacokinetics of nebulized amikacin [ Time Frame: 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.


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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: July 2, 2013
First Posted: July 17, 2013
Last Update Posted: February 1, 2016
Last Verified: January 2016

Keywords provided by Jean-Bernard Michotte, 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