Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Starting soon Phase 3

Inhaled Amikacin Versus Placebo in Patients With Ventilator-associated Tracheobronchitis

NCT07665788 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2026-06-01
Last updated
2026-06-24

Condition(s) studied

Ventilator-Associated PneumoniaVentilator-Associated Tracheobronchitis

Investigational drug(s) / intervention(s)

Optimized and protocolized nebulization procedure.Optimized and protocolized nebulization procedure.

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria: * Age ≥ 18 years * Admission to a participating intensive care unit (ICU) * Invasive mechanical ventilation \> 48 hours * First episode of ventilator-associated tracheobronchitis during the ICU stay defined using the following criteria: (i) purulent tracheobronchial secretions, (iii) no new or progressive persistent pulmonary infiltrate on chest X-ray, and (iv) bacterial growth on endotracheal aspirate ≥10.5 colony-forming unit (CFU)/mL or on bronchoalveolar lavage ≥10.4 CFU/mL or on plugging telescopic catheter ≥10.3 CFU/mL * Coverage by the French health insurance system (Social Security) * Written informed consent obtained from the patient, or, if the patient is not able to give written consent, from his or her legally designated representative (trusted person designated by the patient or, failing that, a family member) or, failing that, inclusion performed by the investigator within the therapeutic window (in such cases, informed consent will be sought by the investigator from the patient, or his or her legally designated representative, whichever is sooner). In all cases, the patient's written informed consent will be obtained as soon as possible. * For woman of childbearing potential: negative pregnancy test result at the time of inclusion Exclusion criteria: * Previous ventilator-associated pneumonia due to the pathogens responsible for ventilator-associated tracheobronchitis during the same ICU stay * On-going antimicrobial therapy fpr ventilator-associated pneumonia * Ventilator-associated tracheobronchitis due to pathogens with intrinsic amikacin resistance (e.g. Stenotrophomonas maltophilia) * On-going therapy with intravenous amikacin or another aminoglycoside * Acute kidney injury stage 2 or 3 of the Kidney Disease Improving Global Outcomes (KDIGO) classification and/or advanced chronic kidney failure (glomerular filtration rate \<30 mL/min), except in patients under renal replacement therapy * Grade B or C cirrhosis (Child-Pugh classification) * Scheduled extubation within 24h * Prior tracheotomy * Administration of inhaled antibiotics within the 7 preceding days * Known hypersensitivity to amikacin, another aminoglycoside, or any of the excipients * Myasthenia gravis * Contraindication to nebulization * On-going treatment with ataluren * Persons covered by articles L1121-5 to L1121-8 of the French Public Health Code (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or trusteeship). * Moribund patient * End-of-life decision * Previous inclusion in the present study * Participation to another interventional study * Inability of the patient, or the person providing consent, to understand all aspects of the research * Patient being a relative of the investigator or a relative of someone from the team directly involved in the trial, including doctors and pharmacists

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)

FacilityCityRegionStatus
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
Official registry record

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