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OpenTrials
Completed

NCT Number: NCT01901497

Pharmacokinetics of Nebulized Amikacin in Non Invasive Ventilated Healthy Volunteers.

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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Key information

Conditions

Acute Respiratory Insufficiency Bites and Stings Bronchial Diseases Bronchial Spasm Bronchospasm and Obstruction Chemically-Induced Disorders Chronic Respiratory Insufficiency Poisoning Respiratory Tract Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires Saint-Luc (Service des soins intensifs)

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nebulizer

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.

Other names: Vibrating-mesh nebulizers

Primary outcomes

  1. Pharmacokinetics of nebulized amikacin

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital St Luc, Brussels

Other

Collaborators

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

Registry information

Official study title

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

Acronym: NIV-NEBU

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jul 17, 2013
Registry last updated
Feb 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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