NCT01901497

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 1, 2016

Status Verified

January 1, 2016

Enrollment Period

1.9 years

First QC Date

July 2, 2013

Last Update Submit

January 29, 2016

Conditions

Acute Respiratory InsufficiencyChronic Respiratory InsufficiencyBronchospasm and Obstruction

Keywords

non invasive ventilationsingle limb circuit ventilatorbilevelnebulizationnebulizervibrating mesh nebulizeramikacin

Outcome Measures

Primary Outcomes (1)

  • 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.

    within the first 24 hours after nebulization

Study Arms (3)

Solo nebulizer

EXPERIMENTAL

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

Device: Nebulizer

Pro nebulizer

EXPERIMENTAL

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

Device: Nebulizer

NIVO nebulizer

EXPERIMENTAL

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

Device: Nebulizer

Interventions

NebulizerDEVICE

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.

Also known as: Vibrating-mesh nebulizers
NIVO nebulizerPro nebulizerSolo nebulizer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No contraindication of amikacin
  • Written informed consent
  • Negative pregnant test (for women)

You may not qualify if:

  • History of respiratory disease
  • History of renal disease
  • History of otological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint-Luc (Service des soins intensifs)

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Bronchial SpasmBites and Stings

Interventions

Nebulizers and Vaporizers

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesPoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Jean-Bernard Michotte, PhD student

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

    PRINCIPAL INVESTIGATOR

  • Emilie Jossen, BSc

    Ligue Pulmonaire Neuchâteloise

    PRINCIPAL INVESTIGATOR

  • Jean Roeseler, PhD

    Cliniques Universitaires Saint-Luc (service des soins intensifs)

    STUDY CHAIR

  • Giuseppe Liistro, MD, PhD

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

    STUDY CHAIR

  • Grégory Reychler, PhD

    Cliniques Universitaires Saint-Luc (service de pneumologie), Université Catholique de Louvain

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, PhD Student

Study Record Dates

First Submitted

July 2, 2013

First Posted

July 17, 2013

Study Start

July 1, 2013

Primary Completion

June 1, 2015

Study Completion

January 1, 2016

Last Updated

February 1, 2016

Record last verified: 2016-01

Locations

BE(1)