Clinical Research Directory
Browse clinical research sites, groups, and studies.
Inhaled Amikacin Versus Placebo in Patients With Ventilator-associated Tracheobronchitis
Sponsor: University Hospital, Tours
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.
Official title: A Multicentre, Double-blind, Randomized Controlled Trial of Inhaled Amikacin Versus Placebo in Critically Ill Patients With Ventilator-associated Tracheobronchitis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2026-06-01
Completion Date
2029-09-01
Last Updated
2026-06-24
Healthy Volunteers
No
Interventions
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).
Locations (17)
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