Inhaled Amikacin Versus Placebo in Patients With Ventilator-associated Tracheobronchitis

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Ventilator-Associated Pneumonia, Ventilator-Associated Tracheobronchitis

In brief

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.

Key facts

Study ID

NCT07665788

Run by

University Hospital, Tours

People needed

250

Starts

2026-06-01

Expected to finish

2029-09-01

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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