Clinical Trial: Study Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Double-blinded Multicenter Randomized Controlled Trial Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia

Brief 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.


Detailed Summary:
Sponsor: University Hospital, Tours

Current Primary Outcome: Incidence of a first VAP episode from randomization to day 28 [ Time Frame: Patients will be followed from randomization to day 28 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of a first VAP episode in the subgroups of patients with tracheobronchial colonization or tracheobronchitis [ Time Frame: At randomization ]
  • Incidence of VAP due to Gram negative amikacin sensitive bacteria [ Time Frame: Patients will be followed from randomization to day 28 ]
  • Clinical pulmonary infection score evolution [ Time Frame: Patients will be followed from randomization to day 28 ]
  • Ventilator associated events incidence [ Time Frame: Patients will be followed from randomization to day 28 ]
  • Number of systemic antibiotics administered per day [ Time Frame: Patients will be followed from randomization to day 28 ]
  • Number of days with at least one administration of a systemic antibiotic [ Time Frame: Patients will be followed from randomization to day 28 ]
  • Incidence of antibiotic resistant bacteria isolated on clinical and hygiene samples [ Time Frame: Patients will be followed from randomization to day 28 ]
  • Incidence of acute kidney injury [ Time Frame: Patients will be followed from randomization to day 28 ]
  • Days spent on mechanical ventilation from randomization to day 90 [ Time Frame: Patients will be followed from randomization to day 90 ]
  • Days from randomization to the first successful spontaneous breathing trial [ Time Frame: Days from randomization to day 90 max ]
  • Days spent in the intensive care unit and in the hospital [ Time Frame: Patients will be followed from randomization to discharge (day 90 max) ]
  • Day 90 mortality [ Time Frame: Day 90 ]
  • Incidence of bacteria producing extended spectrum beta-lactamase or high level derepressed celphalosporinase, of vancomycin resistant Enterococcus Sp. on rectal samples [ Time Frame: Day 28 ]
  • Relative bacterial species composition of respiratory and digestive microbiota [ Time Frame: Patients will be followed from randomization to day 28 ]
  • Maximum serum Concentration [ Time Frame: Between Hour 0-Hour 8, between Hour 8-Hour 16 and between Hour 16-Hour 24 ]
  • Maximum sputum Concentration [ Time Frame: Between Hour 0-Hour 8, between Hour 8-Hour 16 and between Hour 16-Hour 24 ]
  • Area Under the Curve [ Time Frame: Between Hour 0-Hour 8, between Hour 8-Hour 16 and between Hour 16-Hour 24 ]
  • To evaluate the effects on respiratory mechanics of nebulization of amikacin by evaluating the benefit balance / risk [ Time Frame: Measurements at 8 hours, 12 hours and 24 hours after the end of nebulization ]
    benefit : Improvement of respiratory mechanics by pharmacological effect risk : Degradation of respiratory mechanics by bronchospastic secondary effect, drug deposition in the intubation probe


Original Secondary Outcome: Same as current

Information By: University Hospital, Tours

Dates:
Date Received: May 2, 2017
Date Started: June 2017
Date Completion: June 2020
Last Updated: May 9, 2017
Last Verified: May 2017