MedTrace Logo

Study Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia

NCT03149640 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 850

Last updated 2025-12-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • Stephan EHRMANN, MD-PhD · University Hospital, Tours

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-19
Primary Completion
2021-03-09
Completion
2021-06-17

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03149640 on ClinicalTrials.gov