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AMIKINHAL Trial

AMIKINHAL Trial

NEJM

October 25, 2023

Inhaled Amikacin to Prevent Ventilator-Associated Pneumonia

Mazen Kherallah

Summarized by: 

What was the research question?

  • Population: Critically ill adults undergoing invasive mechanical ventilation for at least 72 hours.

  • Intervention: Inhaled amikacin at a dose of 20 mg per kilogram of ideal body weight once daily for 3 days.

  • Comparison: Placebo for 3 days.

  • Outcome: First episode of ventilator-associated pneumonia during 28 days of follow-up.


How did they do it?

  • Study Design: Investigator-initiated, multicenter, double-blind, randomized, controlled, superiority trial.

  • Trial Groups:Amikacin Group: 417 patients
    Placebo Group: 430 patients

  • Primary Outcome: First episode of ventilator-associated pneumonia during 28 days of follow-up.

  • Secondary Outcome: Infection-related ventilator-associated complications.


What were the results?

  • Primary Outcome: Significantly different between the two groups (P=0.004).Amikacin Group: 62 patients (15%) developed ventilator-associated pneumonia.
    Placebo Group: 95 patients (22%) developed ventilator-associated pneumonia.

  • Secondary Outcomes:Infection-related complications were higher in the placebo group compared to the amikacin group.
    Trial-related serious adverse effects were slightly higher in the amikacin group, but the difference was not significantly large.


Are there any limitations of the study?

  • Not all patients received all three daily nebulizations; 81% in the amikacin group and 82% in the placebo group.

  • The trial duration was limited to 28 days, which may not capture long-term effects or complications.


What does it mean?

  • The results indicate that inhaled amikacin can significantly reduce the incidence of ventilator-associated pneumonia in critically ill adults who have been on mechanical ventilation for at least 3 days.

  • This could potentially lead to a change in practices in critical care settings to include inhaled amikacin as a preventive measure for patients on prolonged mechanical ventilation.

  • However, the slight increase in adverse effects in the amikacin group suggests that clinicians should weigh the benefits against potential risks.

  • Further research might be needed to understand the long-term effects and to confirm these findings in larger and more diverse populations.

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