AMIKINHAL
Trial question
What is the role of inhaled amikacin in patients who had undergone mechanical ventilation for at least 3 days?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
34.0% female
66.0% male
N = 847
847 patients (292 female, 555 male)
Inclusion criteria: critically ill adult patients who had undergone mechanical ventilation for at least 3 days
Key exclusion criteria: > 96 hours of invasive mechanical ventilation; suspected or confirmed ventilator-associated pneumonia; severe AKI without RRT; CKD; a tracheostomy tube
Interventions
N=417 amikacin (at a dose of 20 mg/kg of body weight, nebulization TID for 3 days)
N=430 placebo (equivalent volume of 0.9% sodium chloride, nebulization TID for 3 days)
Primary outcome
Rate of first episode of ventilator-associated pneumonia during 28 day follow-up
15
22
22.0 %
16.5 %
11.0 %
5.5 %
0.0 %
Amikacin
Placebo
Significant decrease ▼
NNT = 14
Significant decrease in the rate of first episode of ventilator-associated pneumonia during 28 day follow-up (15% vs. 22%; RR 0.68, 95% CI 0.22 to 1.14)
Secondary outcomes
Borderline significant decrease in ventilator-associated condition (33% vs. 40%; HR 0.79, 95% CI 0.64 to 0.99)
Borderline significant decrease in infection-related ventilator-associated complication (18% vs. 26%; HR 0.66, 95% CI 0.5 to 0.89)
Safety outcomes
No significant differences in serious adverse event, respiratory tract-disorders event.
Significant difference in AKI occurrence during 28 days (4% vs. 8%).
Conclusion
In critically ill adult patients who had undergone mechanical ventilation for at least 3 days, amikacin was superior to placebo with respect to the rate of first episode of ventilator-associated pneumonia during 28 day follow-up.
Reference
Stephan Ehrmann, François Barbier, Julien Demiselle et al. Inhaled Amikacin to Prevent Ventilator-Associated Pneumonia. N Engl J Med. 2023 Oct 25.
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