Pharmacokinetics of Nebulized Amikacin in Non Invasive Ventilated Healthy Volunteers.

Comparison of Pharmacokinetics of Amikacin Administered by Three Vibrating Mesh Nebulizers in Healthy Volunteers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01901497

Acronym

NIV-NEBU

Enrollment

Registered

2013-07-17

Start date

2013-07-31

Completion date

2016-01-31

Last updated

2016-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Insufficiency, Chronic Respiratory Insufficiency, Bronchospasm and Obstruction

Keywords

non invasive ventilation, single limb circuit ventilator, bilevel, nebulization, nebulizer, vibrating mesh nebulizer, amikacin

Brief 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.

Interventions

DEVICENebulizer

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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics of nebulized amikacin	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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026