Inhaled Amikacin Versus Placebo in Patients With Ventilator-associated Tracheobronchitis
Condition(s) studied
Investigational drug(s) / intervention(s)
Optimized and protocolized nebulization procedure.: Patients in the experimental group will receive inhaled amikacin (once daily, 20 mg/kg of predicted body weight with a maximum of 2 grams) from Day 1 (inclusion, randomization and first nebulization) to Day 5 through an optimized and protocolized nebulization procedure (vibrating mesh nebulizer).
Optimized and protocolized nebulization procedure.: Patients in the control group will receive inhaled placebo (NaCl 0.9%, once daily) from Day 1 (inclusion, randomization and first nebulization) to Day 5 through an optimized and protocolized nebulization procedure (vibrating mesh nebulizer).
Study summary
The primary objective of the AMIVAT trial is to assess whether a 5-day course of inhaled amikacin, compared to placebo, reduces the incidence of progression to ventilator-associated pneumonia (VAP) at day 28 in intensive care unit (ICU) patients with ventilator-associated tracheobronchitis (VAT). Transition from VAT to VAP will be defined as the occurrence of a first VAP episode due to the same pathogens than those responsible for VAT.
Eligibility
Primary outcome measure(s)
- Incidence of transition from ventilator-associated tracheobronchitis to ventilator-associated pneumonia at day 28 — From randomization to day 28
Transition from VAT to VAP will be defined as the occurrence of a first VAP episode due to the same pathogens than those responsible for VAT
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| 06 - ANGERS - Intensive care, University Hospital | Angers | France | |
| 04 - ARGENTEUIL - Intensive care, University Hospital | Argenteuil | France | |
| 11 - BLOIS, Intensive care, Hospital | Blois | France | |
| 09 - BOURG-EN-BRESSE, Intensive care, Hospital | Bourg-en-Bresse | France | |
| 10 - HENRI MONDOR, Intensive care, University Hospital | Créteil | France | |
| 07 - DIEPPE - Intensive care, University Hospital | Dieppe | France | |
| 08 - DIJON - Intensive care, University Hospital | Dijon | France | |
| 12 - DREUX, Intensive care, Hospital | Dreux | France | |
| 14 - VERSAILLES, Intensive care, Hospital | Le Chesnay | France | |
| 05 - LE MANS - Intensive care, University Hospital | Le Mans | France | |
| 15 - LYON EH, Intensive care, University Hospital | Lyon | France | |
| 01 - ORLEANS - Intensive care, University Hospital | Orléans | France | |
| 17 - LOUIS MOURIER, Intensive care, University Hospital | Paris | France | |
| 13 - BICHAT, Intensive care, Univerity Hospital | Paris | France | |
| 16 - LYON SUD, Intensive care, University Hospital | Pierre-Bénite | France | |
| 03 - STRASBOURG - Intensive care, University Hospital | Strasbourg | France | |
| 02 - TOURS - Intensive care, University Hospital | Tours | France |
More University Hospital, Tours trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07665788 on ClinicalTrials.gov ↗ ← All trials in France