Pharmacokinetics of Nebulized Amikacin in Non Invasive Ventilated Healthy Volunteers.
Information source: University Hospital St Luc, Brussels
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Respiratory Insufficiency; Chronic Respiratory Insufficiency; Bronchospasm and Obstruction
Intervention: Nebulizer (Device)
Phase: N/A
Status: Recruiting
Sponsored by: University Hospital St Luc, Brussels Official(s) and/or principal investigator(s):
Jean-Bernard Michotte, PhD student, Principal Investigator, Affiliation: Cliniques Universitaires Saint-Luc (service de pneumologie), Haute Ecole de Santé Vaud (filière physiothérapie), Université Catholique de Louvain
Emilie Jossen, BSc, Principal Investigator, Affiliation: Ligue pulmonaire neuchâteloise
Jean Roeseler, PhD, Study Chair, Affiliation: Cliniques Universitaires Saint-Luc (service des soins intensifs)
Giuseppe Liistro, MD, PhD, Study Chair, Affiliation: Université Catholique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Pôle de Pneumologie, ORL & Dermatologie, 1200 Brussels, Belgium
Grégory Reychler, PhD, Study Director, Affiliation: Cliniques Universitaires Saint-Luc (service de pneumologie), Université Catholique de Louvain
Overall contact:
Jean-Bernard Michotte, PhD student, Email: jean-bernard.michotte@hesav.ch
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.
Clinical Details
Official title: Comparison of Pharmacokinetics of Amikacin Administered by Three Vibrating Mesh Nebulizers in Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Pharmacokinetics of nebulized amikacin
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Jean-Bernard Michotte, PhD student, Email: jean-bernard.michotte@hesav.ch
Cliniques Universitaires Saint-Luc (Service des soins intensifs), Brussels 1200, Belgium; Recruiting
Jean-Bernard Michotte, PhD Student, Phone: 0041213168115, Email: jean-bernard.michotte@hesav.ch
Grégory Reychler, PhD, Email: gregory.reychler@uclouvain.be
Jean-Bernard Michotte, PhD student, Principal Investigator
Grégory Reychler, PhD, Sub-Investigator
Additional Information
Starting date: July 2013
Last updated: June 5, 2015
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