Acute Respiratory InsufficiencyNIV-NEBUNCT01901497
Pharmacokinetics of Nebulized Amikacin in Non Invasive Ventilated Healthy Volunteers.
A study testing Nebulizer in people with Acute Respiratory Insufficiency and Chronic Respiratory Insufficiency, run by University Hospital St Luc, Brussels at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Insufficiency, Chronic Respiratory Insufficiency, Bronchospasm and Obstruction
- What is being tested?
- Nebulizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2013to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No contraindication of amikacin
- Written informed consent
- Negative pregnant test (for women)
Who cannot join
- History of respiratory disease
- History of renal disease
- History of otological disease
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Cliniques Universitaires Saint-Luc (Service des soins intensifs)
Brussels, 1200
About this study
Official title: Comparison of Pharmacokinetics of Amikacin Administered by Three Vibrating Mesh Nebulizers in 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.
- Conditions
- Acute Respiratory Insufficiency, Chronic Respiratory Insufficiency, Bronchospasm and Obstruction
- Being tested
- Nebulizer
- Keywords
- non invasive ventilation, single limb circuit ventilator, bilevel, nebulization, nebulizer, vibrating mesh nebulizer, amikacin
- Medical subject headings
- Bronchial Spasm, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NebulizerDevice
Also called Vibrating-mesh nebulizers
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.
| Study group | Role | What they receive |
|---|---|---|
| Solo nebulizer | Experimental | Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb Solo nebulizer associated with a bilevel ventilator Receives: Device: Nebulizer |
| Pro nebulizer | Experimental | Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb Pro nebulizer associated with a bilevel ventilator Receives: Device: Nebulizer |
| NIVO nebulizer | Experimental | Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb NIVO nebulizer associated with a bilevel ventilator Receives: Device: Nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within the first 24 hours after nebulization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital St Luc, Brussels
- Sponsor type
- University, hospital or other
- Collaborators
- Haute Ecole de Santé Vaud, Université Catholique de Louvain, Ligue Pulmonaire Neuchâteloise
- Responsible party
- Principal investigator, Jean-Bernard Michotte, University Hospital St Luc, Brussels
- Investigators
- Jean-Bernard Michotte, PhD student, Principal investigator, Cliniques Universitaires Saint-Luc (service de pneumologie), Haute Ecole de Santé Vaud (filière physiothérapie), Université Catholique de LouvainEmilie Jossen, BSc, Principal investigator, Ligue Pulmonaire NeuchâteloiseJean Roeseler, PhD, Study chair, Cliniques Universitaires Saint-Luc (service des soins intensifs)Giuseppe Liistro, MD, PhD, Study chair, Université Catholique de Louvain, Institut de Recherche Expérimentale et Clinique (IREC), Pôle de Pneumologie, ORL & Dermatologie, 1200 Brussels, BelgiumGrégory Reychler, PhD, Study director, Cliniques Universitaires Saint-Luc (service de pneumologie), Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901497
- Sponsor's protocol ID
- NIVnebu
- Acronym
- NIV-NEBU
- Status last verified
- Jan 2016
- First submitted
- 2 Jul 2013
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pharmacokinetics of Amikacin Administered by Three Vibrating Mesh Nebulizers in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01901497
- Acronym / sponsor ID
- NIV-NEBU / NIVnebu
- Conditions
- Acute Respiratory Insufficiency, Chronic Respiratory Insufficiency, Bronchospasm and Obstruction
- Keywords
- non invasive ventilation, single limb circuit ventilator, bilevel, nebulization, nebulizer, vibrating mesh nebulizer, amikacin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital St Luc, BrusselsUniversity, hospital or other
- Collaborators
- Haute Ecole de Santé Vaud, Université Catholique de Louvain, Ligue Pulmonaire Neuchâteloise
- Study start
- Jul 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 17 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Solo nebulizer | Experimental | Device: NebulizerAmikacin (500 mg/4 mL) administered with an Aerogen AeroNeb Solo nebulizer associated with a bilevel ventilator |
| Pro nebulizer | Experimental | Device: NebulizerAmikacin (500 mg/4 mL) administered with an Aerogen AeroNeb Pro nebulizer associated with a bilevel ventilator |
| NIVO nebulizer | Experimental | Device: NebulizerAmikacin (500 mg/4 mL) administered with an Aerogen AeroNeb NIVO nebulizer associated with a bilevel ventilator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- No contraindication of amikacin
- Written informed consent
- Negative pregnant test (for women)
Key exclusion criteria (3 listed)
- History of respiratory disease
- History of renal disease
- History of otological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NebulizerAlso: Vibrating-mesh nebulizers500 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. | Device | NIVO nebulizer, Pro nebulizer, Solo nebulizer |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
Related trials for Acute Respiratory Insufficiency
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Bernard Michotte, PhD student principal investigator
Cliniques Universitaires Saint-Luc (service de pneumologie), Haute Ecole de Santé Vaud (filière physiothérapie), Université Catholique de Louvain
Emilie Jossen, BSc principal investigator
Ligue Pulmonaire Neuchâteloise
Jean Roeseler, PhD study chair
Cliniques Universitaires Saint-Luc (service des soins intensifs)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nebulizer in people with Acute Respiratory Insufficiency and Chronic Respiratory Insufficiency, run by University Hospital St Luc, Brussels at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of nebulized amikacin (time frame: within the first 24 hours after nebulization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2016.