NCT03149640

Study Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 850 (actual)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pneumonia, Ventilator-Associated

Interventions

Type	Name	Description
DRUG	Inhaled amikacin	Once a day, inhaled amikacin at day 4, day 5 and day 6 of invasive mechanical ventilation: 20 mg/kg of ideal body weight, maximum 2 g per day.
DRUG	Inhaled placebo	Once a day, inhaled placebo at day 4, day 5 and day 6 of invasive mechanical ventilation.

Timeline

• Start date: 2017-07-19
• Primary completion: 2021-03-09
• Completion: 2021-06-17
• First posted: 2017-05-11
• Last updated: 2025-12-22

Locations

18 sites across 1 country: France