Ventilator Associated PneumoniaPhase 2/3DARTAGNANNCT00861315
Pharmacokinetics of Nebulized Amikacin in Patients With Pneumonia Undergoing Mechanical Ventilation
A Phase 2/3 study testing Nebulized amikacin and Intravenous amikacin in people with Ventilator Associated Pneumonia, run by Association Pour La Promotion A Tours De La Reanimation Medicale at 2 sites in France.
Trial summary
Inclusion of patients undergoing mechanical ventilation and presenting a pneumonia in order to determine serum pharmacokinetics of nebulized amikacin. The primary aim is to determine the dose of amikacin to be nebulized in order to observe amikacin serum concentrations close to but inferior to those observed after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Nebulized amikacin and Intravenous amikacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2009to Jan 2011
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to intensive care unit.
- Patients undergoing mechanical ventilation for more than 48H.
- Suspicion of ventilator associated pneumonia.
Who cannot join
- Allergy to amikacin or any compound of the medication.
- Body mass index > 30 kg/m2.
- Myasthenia gravis.
- Acute or chronic renal failure.
- Vestibulo-cochlear disease.
- Pregnancy.
- Brain death.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Service de réanimation médicale. Hôpital La Source. CH Orléans
Orléans, Loiret, F45067
Thierry Boulain, MD, +33(0)238514446, thierry.boulain@chr-orleans.fr
Thierry Boulain, MD
- Recruiting
Service de réanimation médicale polyvalente. Hôpital Bretonneau CHRU
Tours, Indre et Loire, F37044
Stephan Ehrmann, MD, +33(0)671103302, stephanehrmann@gmail.com
Stephan Ehrmann, MD
About this study
Official title: Phase II Study of High Dose Nebulized Amikacin in Patients With Pneumonia Undergoing Mechanical Ventilation
Inclusion of patients undergoing mechanical ventilation and presenting a pneumonia in order to determine serum pharmacokinetics of nebulized amikacin. The primary aim is to determine the dose of amikacin to be nebulized in order to observe amikacin serum concentrations close to but inferior to those observed after standart intravenous amikacin infusion.
Read the detailed description
After inclusion, patients undergo intravenous infusion of 20 mg/Kg of amikacin with amikacin serum concentrations being monitored over the following 24 hours.
Randomization occures after this first amikacin infusion. Patients are randomized to group nebulized amikacin or intravenous amikacin. The three next days of the study patients recieve nebulized amikacin (or nebulized placebo) during mechanical ventilation and a placebo infusion (amikacin infusion in case of placebo nebulization) using a air driven jet nebulizer. Amikacin serum concentrations are monitored over 24 hours after each nebulization.
Patients are followed up during 10 days for safety and efficacy. The dose of amikacin to be nebulized is 60 mg/Kg for the first 6 patients (phase A), 80 mg/Kg for the next 6 patients (phase B) and 100 mg/Kg for the last 6 patients (phase C). Each phase is started after review of the results of the preceeding phase by an idependent safety and monitoring board.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Nebulized amikacin, Intravenous amikacin, Placebo nebulization, Placebo infusion
- Keywords
- Pneumonia, Nebulization, Amikacin
- Medical subject headings
- Pneumonia, Ventilator-Associated, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized amikacinDrug
Amikacin is nebulized at a dose of 60 mg/Kg (6 first patients of the arm), 80 mg/Kg (6 subsequent patients) or 100 mg/Kg (last 6 patients of the arm)
Intravenous amikacinDrug
20 mg/Kg amikacin are administred intravenousely once a day during three days.
Placebo nebulizationDrug
0.9% saline solution is nebulized once a day during three days
Placebo infusionDrug
0.9% saline is administered intravenousely once a day during three days
| Study group | Role | What they receive |
|---|---|---|
| Nebulized amikacin | Experimental | Patients receive nebulized amikacin once a day during three days. Placebo is administered intravenousely Receives: Drug: Nebulized amikacin; Drug: Placebo infusion |
| Intravenous amikacin | Active comparator | Not described Receives: Drug: Intravenous amikacin; Drug: Placebo nebulization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determintion of nebulized amikacin dose (60 mg/Kg, 80 mg/Kg or 100 mg/Kg) which results in serum amikacin concentrations equal or below the serum amikacin concentrations measured after 20 mg/Kg intravenous amikacin infusion
Secondary outcomes (4)
Comparison of clinical pulmonary infection score evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin
Measured: 10 days
Comparison of serum procalcitonin concentration evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin
Measured: 10 days
Comparison of c reactive protein evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin
Measured: 10 days
Comparison duration of mechanical ventilation between patients treated with nebulized amikacin and patients treated with intravenous amikacin
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2011 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Pour La Promotion A Tours De La Reanimation Medicale
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861315
- Sponsor's protocol ID
- DARTAGNAN
- Acronym
- DARTAGNAN
- Status last verified
- Mar 2009
- First submitted
- 12 Mar 2009
- Last updated
- 16 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of High Dose Nebulized Amikacin in Patients With Pneumonia Undergoing Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT00861315
- Acronym / sponsor ID
- DARTAGNAN / DARTAGNAN
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- Pneumonia, Nebulization, Amikacin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Association Pour La Promotion A Tours De La Reanimation MedicaleUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 13 Mar 2009 (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.
Inclusion of patients undergoing mechanical ventilation and presenting a pneumonia in order to determine serum pharmacokinetics of nebulized amikacin. The primary aim is to determine the dose of amikacin to be nebulized in order to observe amikacin serum concentrations close to but inferior to those observed after standart intravenous amikacin infusion.
Detailed description
After inclusion, patients undergo intravenous infusion of 20 mg/Kg of amikacin with amikacin serum concentrations being monitored over the following 24 hours.
Randomization occures after this first amikacin infusion. Patients are randomized to group nebulized amikacin or intravenous amikacin. The three next days of the study patients recieve nebulized amikacin (or nebulized placebo) during mechanical ventilation and a placebo infusion (amikacin infusion in case of placebo nebulization) using a air driven jet nebulizer. Amikacin serum concentrations are monitored over 24 hours after each nebulization.
Patients are followed up during 10 days for safety and efficacy. The dose of amikacin to be nebulized is 60 mg/Kg for the first 6 patients (phase A), 80 mg/Kg for the next 6 patients (phase B) and 100 mg/Kg for the last 6 patients (phase C). Each phase is started after review of the results of the preceeding phase by an idependent safety and monitoring board.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulized amikacin | Experimental | Drug: Nebulized amikacin, Drug: Placebo infusionPatients receive nebulized amikacin once a day during three days. Placebo is administered intravenousely |
| Intravenous amikacin | Active comparator | Drug: Intravenous amikacin, Drug: Placebo nebulization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted to intensive care unit.
- Patients undergoing mechanical ventilation for more than 48H.
- Suspicion of ventilator associated pneumonia.
Key exclusion criteria (7 listed)
- Allergy to amikacin or any compound of the medication.
- Body mass index > 30 kg/m2.
- Myasthenia gravis.
- Acute or chronic renal failure.
- Vestibulo-cochlear 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 |
|---|---|---|
| Nebulized amikacinAmikacin is nebulized at a dose of 60 mg/Kg (6 first patients of the arm), 80 mg/Kg (6 subsequent patients) or 100 mg/Kg (last 6 patients of the arm) | Drug | Nebulized amikacin |
| Intravenous amikacin20 mg/Kg amikacin are administred intravenousely once a day during three days. | Drug | Intravenous amikacin |
| Placebo nebulization0.9% saline solution is nebulized once a day during three days | Drug | Intravenous amikacin |
| Placebo infusion0.9% saline is administered intravenousely once a day during three days | Drug | Nebulized amikacin |
Primary outcome
Determintion of nebulized amikacin dose (60 mg/Kg, 80 mg/Kg or 100 mg/Kg) which results in serum amikacin concentrations equal or below the serum amikacin concentrations measured after 20 mg/Kg intravenous amikacin infusion
4 secondary outcomes
Comparison of clinical pulmonary infection score evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin
Time frame: 10 days
Comparison of serum procalcitonin concentration evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin
Time frame: 10 days
Comparison of c reactive protein evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin
Time frame: 10 days
Comparison duration of mechanical ventilation between patients treated with nebulized amikacin and patients treated with intravenous amikacin
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2009.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nebulized amikacin and Intravenous amikacin in people with Ventilator Associated Pneumonia, run by Association Pour La Promotion A Tours De La Reanimation Medicale at 2 sites in France.
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 7 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: status not confirmed, as of the sponsor's last update on 16 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephan Ehrmann, MD (+33(0)671103302, stephanehrmann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determintion of nebulized amikacin dose (60 mg/Kg, 80 mg/Kg or 100 mg/Kg) which results in serum amikacin concentrations equal or below the serum amikacin concentrations measured after 20 mg/Kg intravenous amikacin infusion. 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 16 Mar 2009.