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

University Hospital St Luc, Brussels

Status: Completed

Conditions: Acute Respiratory Insufficiency; Chronic Respiratory Insufficiency; Bronchospasm and Obstruction

Treatments: Device: Nebulizer

Study type: Interventional

Funder types: Other

Identifiers

NCT01901497

NIVnebu

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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7 participants in 3 patient groups

Solo nebulizer

Experimental group

Description:

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

Treatment:

Device: Nebulizer

Pro nebulizer

Experimental group

Description:

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

Treatment:

Device: Nebulizer

NIVO nebulizer

Experimental group

Description:

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

Treatment:

Device: Nebulizer