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Pharmacokinetics of Nebulized Amikacin in Non Invasive Ventilated Healthy Volunteers.

NCT01901497 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2016-02-01

No results posted yet for this study

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.

Conditions

  • Acute Respiratory Insufficiency
  • Chronic Respiratory Insufficiency
  • Bronchospasm and Obstruction

Interventions

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.

Sponsors & Collaborators

  • Haute Ecole de Santé Vaud

    collaborator OTHER

  • Université Catholique de Louvain

    collaborator OTHER

  • Ligue Pulmonaire Neuchâteloise

    collaborator OTHER

  • University Hospital St Luc, Brussels

    lead OTHER

Principal Investigators

  • Jean-Bernard Michotte, PhD student · Cliniques Universitaires Saint-Luc (service de pneumologie), Haute Ecole de Santé Vaud (filière physiothérapie), Université Catholique de Louvain

  • Emilie Jossen, BSc · Ligue Pulmonaire Neuchâteloise

  • Jean Roeseler, PhD · Cliniques Universitaires Saint-Luc (service des soins intensifs)

  • Giuseppe Liistro, MD, PhD · Université Catholique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Pôle de Pneumologie, ORL & Dermatologie, 1200 Brussels, Belgium

  • Grégory Reychler, PhD · Cliniques Universitaires Saint-Luc (service de pneumologie), Université Catholique de Louvain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2015-06-30
Completion
2016-01-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01901497 on ClinicalTrials.gov