Study Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia
NCT ID: NCT03149640
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
850 participants
INTERVENTIONAL
2017-07-19
2021-06-17
Brief Summary
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Parallel two group double blind randomized controlled clinical trial. Individual randomization, performed on day 4 of invasive mechanical ventilation, will be stratified on centre in order to account for variations in VAP prevention bundle implementation and use of systemic antibiotics the day of randomization. Patients will be treated three consecutive days with inhaled amikacin or placebo. Patients will be followed up daily in the intensive care unit for the occurrence of VAP according to international guidelines until day 28.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Inhaled amikacin
Inhaled amikacin at day 4, day 5 and day 6 of invasive mechanical ventilation: 20 mg/kg of ideal body weight, maximum 2 g per day.
Inhaled amikacin
Once a day, inhaled amikacin at day 4, day 5 and day 6 of invasive mechanical ventilation: 20 mg/kg of ideal body weight, maximum 2 g per day.
Placebo
Once a day, inhaled placebo at day 4, day 5 and day 6 of invasive mechanical ventilation.
Inhaled placebo
Once a day, inhaled placebo at day 4, day 5 and day 6 of invasive mechanical ventilation.
Interventions
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Inhaled amikacin
Once a day, inhaled amikacin at day 4, day 5 and day 6 of invasive mechanical ventilation: 20 mg/kg of ideal body weight, maximum 2 g per day.
Inhaled placebo
Once a day, inhaled placebo at day 4, day 5 and day 6 of invasive mechanical ventilation.
Eligibility Criteria
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Inclusion Criteria
* Mechanical ventilation through an endotracheal tube for more than three consecutive days (72h)
* Written informed consent of the patient or a proxy
* Patients covered by or having the rights to French social security
* Negative pregnancy test, at the time of inclusion, in women of childbearing potential
Exclusion Criteria
* Clinical indication for systemic aminoglycoside therapy the day of inclusion : as deemed necessary by the clinician in charge
* Stage 2 or 3 KDIGO\* classification acute kidney injury the day of inclusion excepted in patients undergoing renal replacement therapy
* Chronic kidney failure : baseline glomerular filtration lower than 30 mL/min
* Patient scheduled for extubation within the next 24h
* Patient ventilated through an endotracheal tube for more than four consecutive days before inclusion (96h)
* Patient ventilated through a tracheostomy
* Patients allergic to aminoglycosides
* Myasthenia gravis
* Known pregnant women at the time of inclusion and lactating patients
* Known guardianship or trusteeship at the time of inclusion
* Patients previously included in this study
18 Years
ALL
No
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Stephan EHRMANN, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Tours
Locations
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Service de Réanimation Chirurgicale
Angers, , France
Service de Réanimation Médicale - CH d'Angoulême
Angoulême, , France
Service de Réanimation Polyvalente
Argenteuil, , France
Service de Réanimation Médicale - Hôpital Louis Mourier
Colombes, , France
Service de Réanimation
Dijon, , France
Service de Réanimation Médicale - CHD Les Oudairies
La Roche-sur-Yon, , France
Service de Réanimation
Le Mans, , France
Service de Réanimation Médicale - Hôpital La Croix-Rousse
Lyon, , France
Service de Réanimation Médicale
Orléans, , France
Service de Réanimation Médicale - Hôpital Pitié Salpêtrière
Paris, , France
Service de Réanimation Médicale - CHU La Milétrie
Poitiers, , France
Service de Réanimation Médicale
Poitiers, , France
Service de Réanimation Médicale - CHU Pontchaillou
Rennes, , France
Service de Réanimation Médicale - CHU Rouen
Rouen, , France
Service de Réanimation Médicale - Hôpital Charles Nicolle
Rouen, , France
Service de Réanimation - NHC
Strasbourg, , France
Service de Réanimation Médicale - Hôpital de Hautepierre
Strasbourg, , France
Service de Réanimation médicale, Hôpital Trousseau
Tours, , France
Countries
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References
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Tavernier E, Barbier F, Meziani F, Quenot JP, Herbrecht JE, Landais M, Roux D, Seguin P, Schnell D, Veinstein A, Veber B, Lasocki S, Lu Q, Beduneau G, Ferrandiere M, Dahyot-Fizelier C, Plantefeve G, Nay MA, Merdji H, Andreu P, Vecellio L, Muller G, Cabrera M, Le Pennec D, Respaud R, Lanotte P, Gregoire N, Leclerc M, Helms J, Boulain T, Lacherade JC, Ehrmann S; REVA network and the CRICS-TRIGGESEP F-CRIN network. Inhaled amikacin versus placebo to prevent ventilator-associated pneumonia: the AMIKINHAL double-blind multicentre randomised controlled trial protocol. BMJ Open. 2021 Sep 14;11(9):e048591. doi: 10.1136/bmjopen-2020-048591.
Ehrmann S, Barbier F, Demiselle J, Quenot JP, Herbrecht JE, Roux D, Lacherade JC, Landais M, Seguin P, Schnell D, Veinstein A, Gouin P, Lasocki S, Lu Q, Beduneau G, Ferrandiere M, Plantefeve G, Dahyot-Fizelier C, Chebib N, Mercier E, Heuze-Vourc'h N, Respaud R, Gregoire N, Garot D, Nay MA, Meziani F, Andreu P, Clere-Jehl R, Zucman N, Azais MA, Saint-Martin M, Gandonniere CS, Benzekri D, Merdji H, Tavernier E; Reva and CRICS-TRIGGERSEP F-CRIN Research Networks. Inhaled Amikacin to Prevent Ventilator-Associated Pneumonia. N Engl J Med. 2023 Nov 30;389(22):2052-2062. doi: 10.1056/NEJMoa2310307. Epub 2023 Oct 25.
Other Identifiers
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PHRN15-SE / AMIKINHAL
Identifier Type: -
Identifier Source: org_study_id