This study involves patients who are critically ill and on a breathing machine who have developed ventilator-associated tracheobronchitis, which is an infection of the airways that can occur when a person needs help breathing through a tube in their windpipe for several days. The treatment being tested is amikacin, an antibiotic that will be given through inhalation as a mist directly into the lungs using a special device called a nebulizer, rather than being given through a vein or by mouth as it is normally used. Some patients will receive amikacin while others will receive placebo. The study will also use sodium chloride solution for the preparation of the treatments.
The purpose of the study is to find out whether giving inhaled amikacin for five days can reduce the chance that the airway infection will get worse and turn into ventilator-associated pneumonia, which is a more serious lung infection. The study will compare patients who receive the antibiotic treatment to those who receive placebo to see if there is a difference in how many patients develop this more serious lung infection within 28 days.
During the study, patients will receive either inhaled amikacin or placebo once a day for five days through the nebulizer device that is connected to the breathing machine. Doctors will monitor patients closely to see if the airway infection improves or worsens, how long patients need to stay on the breathing machine, how long they stay in the intensive care unit and hospital, and whether any side effects occur. The study will also look at other outcomes such as survival rates at 28 and 90 days, the amount of other antibiotics needed, whether new infections develop, and the quality of life for patients who survive after 90 days.
France 
