Pharmacokinetics of Nebulized Amikacin in Non Invasive Ventilated Healthy Volunteers.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Respiratory Insufficiency Chronic Respiratory Insufficiency Bronchospasm and Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Solo nebulizer

Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb Solo nebulizer associated with a bilevel ventilator

Group Type EXPERIMENTAL

Nebulizer

Intervention Type DEVICE

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.

Pro nebulizer

Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb Pro nebulizer associated with a bilevel ventilator

Group Type EXPERIMENTAL

Nebulizer

Intervention Type DEVICE

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.

NIVO nebulizer

Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb NIVO nebulizer associated with a bilevel ventilator

Group Type EXPERIMENTAL

Nebulizer

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Vibrating-mesh nebulizers

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Jean-Bernard Michotte

MSc, PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean-Bernard Michotte, PhD student

Role: PRINCIPAL_INVESTIGATOR

Cliniques Universitaires Saint-Luc (service de pneumologie), Haute Ecole de Santé Vaud (filière physiothérapie), Université Catholique de Louvain

Emilie Jossen, BSc

Role: PRINCIPAL_INVESTIGATOR

Ligue Pulmonaire Neuchâteloise

Jean Roeseler, PhD

Role: STUDY_CHAIR

Cliniques Universitaires Saint-Luc (service des soins intensifs)

Giuseppe Liistro, MD, PhD

Role: STUDY_CHAIR

Université Catholique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Pôle de Pneumologie, ORL & Dermatologie, 1200 Brussels, Belgium