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

Primary Purpose

Acute Respiratory Insufficiency, Chronic Respiratory Insufficiency, Bronchospasm and Obstruction

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Nebulizer

About this trial

This is an interventional treatment trial for Acute Respiratory Insufficiency focused on measuring non invasive ventilation, single limb circuit ventilator, bilevel, nebulization, nebulizer, vibrating mesh nebulizer, amikacin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Cliniques Universitaires Saint-Luc (Service des soins intensifs)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Solo nebulizer

Pro nebulizer

NIVO nebulizer

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Pharmacokinetics of nebulized amikacin

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01901497

First Posted

July 2, 2013

Last Updated

January 29, 2016

Sponsor

University Hospital St Luc, Brussels

Collaborators

Haute Ecole de Santé Vaud, Université Catholique de Louvain, Ligue Pulmonaire Neuchâteloise

1. Study Identification

Unique Protocol Identification Number

NCT01901497

Brief Title

Pharmacokinetics of Nebulized Amikacin in Non Invasive Ventilated Healthy Volunteers.

Acronym

NIV-NEBU

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital St Luc, Brussels

Collaborators

Haute Ecole de Santé Vaud, Université Catholique de Louvain, Ligue Pulmonaire Neuchâteloise

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Insufficiency, Chronic Respiratory Insufficiency, Bronchospasm and Obstruction

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Solo nebulizer

Arm Type

Experimental

Arm Description

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

Arm Title

Pro nebulizer

Arm Type

Experimental

Arm Description

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

Arm Title

NIVO nebulizer

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Nebulizer

Other Intervention Name(s)

Vibrating-mesh nebulizers

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pharmacokinetics of nebulized amikacin

Description

Time Frame

within the first 24 hours after nebulization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: