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NOT YET RECRUITING
NCT07665788
PHASE3

Inhaled Amikacin Versus Placebo in Patients With Ventilator-associated Tracheobronchitis

Sponsor: University Hospital, Tours

View on ClinicalTrials.gov

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

DRUG

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).

DRUG

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