Study Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia

  • STATUS
    Recruiting
  • End date
    Apr 1, 2022
  • participants needed
    850
  • sponsor
    University Hospital, Tours
Updated on 1 March 2021
antibiotic therapy
antibiotics
mechanical ventilation

Summary

The objective of the study is to prove that after the third day of invasive mechanical ventilation a three-day course of inhaled amikacin reduces the incidence of subsequent VAP.

Parallel two group double blind randomized controlled clinical trial. Individual randomization, performed on day 4 of invasive mechanical ventilation, will be stratified on centre in order to account for variations in VAP prevention bundle implementation and use of systemic antibiotics the day of randomization. Patients will be treated three consecutive days with inhaled amikacin or placebo. Patients will be followed up daily in the intensive care unit for the occurrence of VAP according to international guidelines until day 28.

Details
Condition Ventilator associated pneumonia
Treatment inhaled placebo, Inhaled amikacin
Clinical Study IdentifierNCT03149640
SponsorUniversity Hospital, Tours
Last Modified on1 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

as deemed necessary by the clinician in charge
Stage 2 or 3 KDIGO classification acute kidney injury the day of inclusion excepted in patients undergoing renal replacement therapy
Chronic kidney failure : baseline glomerular filtration lower than 30 mL/min
Patient scheduled for extubation within the next 24h
Patient ventilated through an endotracheal tube for more than four consecutive days before inclusion (96h)
Patient ventilated through a tracheostomy
Patients allergic to aminoglycosides
Myasthenia gravis
Known pregnant women at the time of inclusion and lactating patients
Known guardianship or trusteeship at the time of inclusion
Patients previously included in this study

Exclusion Criteria

Suspicion or confirmed VAP the day of inclusion
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