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| Name | Class |
|---|---|
| Haute Ecole de Santé Vaud | OTHER |
| Université Catholique de Louvain | OTHER |
| Ligue Pulmonaire Neuchâteloise | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solo nebulizer | Experimental | Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb Solo nebulizer associated with a bilevel ventilator |
|
| Pro nebulizer | Experimental | Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb Pro nebulizer associated with a bilevel ventilator |
|
| NIVO nebulizer | Experimental | Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb NIVO nebulizer associated with a bilevel ventilator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint-Luc (Service des soins intensifs) | Brussels | 1200 | Belgium |
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| ID | Term |
|---|---|
| D001986 | Bronchial Spasm |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D009330 | Nebulizers and Vaporizers |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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|
| D014947 |
| Wounds and Injuries |