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Status unknownNCT00861315DARTAGNANUpdated Mar 16, 2009

Pharmacokinetics of Nebulized Amikacin in Patients With Pneumonia Undergoing Mechanical Ventilation

A Phase 2/3 interventional study of Nebulized amikacin and Intravenous amikacin in Ventilator Associated Pneumonia, sponsored by Association Pour La Promotion A Tours De La Reanimation Medicale. Status unknown at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-03-16.

Sponsored by Association Pour La Promotion A Tours De La Reanimation Medicale · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Ventilator Associated Pneumonia

Keywords

  • Pneumonia
  • Nebulization
  • Amikacin
03

In context

Pneumonia, Ventilator-Associated

405 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 85 are open to participants now.

This study's planned enrollment of 24 is below the median of 120 across 264 interventional studies indexed under Pneumonia, Ventilator-Associated.

Browse Pneumonia, Ventilator-Associated studies →

Lead sponsor

Association Pour La Promotion A Tours De La Reanimation Medicale is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients admitted to intensive care unit.
  • Patients undergoing mechanical ventilation for more than 48H.
  • Suspicion of ventilator associated pneumonia.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Nebulized amikacin

    Patients receive nebulized amikacin once a day during three days. Placebo is administered intravenousely

    Drug: Nebulized amikacin · Drug: Placebo infusion

  • Active comparator
    Intravenous amikacin

    Drug: Intravenous amikacin · Drug: Placebo nebulization

Interventions

  • DrugNebulized amikacin

    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)

  • DrugIntravenous amikacin

    20 mg/Kg amikacin are administred intravenousely once a day during three days.

  • DrugPlacebo nebulization

    0.9% saline solution is nebulized once a day during three days

  • DrugPlacebo infusion

    0.9% saline is administered intravenousely once a day during three days

06

What researchers measure

Primary outcomes

  1. 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

  1. Comparison of clinical pulmonary infection score evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin

    Time frame: 10 days

  2. Comparison of serum procalcitonin concentration evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin

    Time frame: 10 days

  3. Comparison of c reactive protein evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin

    Time frame: 10 days

  4. Comparison duration of mechanical ventilation between patients treated with nebulized amikacin and patients treated with intravenous amikacin

    Time frame: 10 days

07

Study locations

2 of 2 sites recruiting
  • Service de réanimation médicale polyvalente. Hôpital Bretonneau CHRU
    Tours, Indre et Loire F37044, France
    • Stephan Ehrmann, MD · Contact · stephanehrmann@gmail.com · +33(0)671103302
    • Stephan Ehrmann, MD · Principal investigator
    • Emmanuelle Mercier, MD · Sub investigator
    • Pierre-François Dequin, MD, PhD · Sub investigator
    • Denis Garot, MD · Sub investigator
    • Annick Legras, MD · Sub investigator
    • Dominique Perrotin, MD · Sub investigator
    Recruiting
  • Service de réanimation médicale. Hôpital La Source. CH Orléans
    Orléans, Loiret F45067, France
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2009, a primary completion of Jan 2011 and a completion of Jan 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 12, 2009
First posted
Mar 13, 2009
Start
Jan 2009
Primary completionEst.
Jan 2011
CompletionEst.
Jan 2011
Last update
Mar 16, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 16, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00861315
Lead sponsor
Association Pour La Promotion A Tours De La Reanimation Medicale
First posted
Mar 13, 2009
Start date
Jan 2009
Primary completion
Jan 2011 (estimated)
Completion
Jan 2011 (estimated)
Last update
Mar 16, 2009

Study contacts

Stephan Ehrmann, MD
Contact
stephanehrmann@gmail.com
+33(0)671103302

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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