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The objective of the study is to prove that after the third day of invasive mechanical ventilation a three-day course of inhaled amikacin reduces the incidence of subsequent VAP.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled amikacin | Experimental | 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 | Placebo Comparator | Once a day, inhaled placebo at day 4, day 5 and day 6 of invasive mechanical ventilation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled amikacin | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of a first VAP episode from randomization to day 28 | Patients will be followed from randomization to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of a first VAP episode in the subgroups of patients with tracheobronchial colonization or tracheobronchitis | At randomization | |
| Incidence of VAP due to Gram negative amikacin sensitive bacteria | Patients will be followed from randomization to day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan EHRMANN, MD-PhD | University Hospital, Tours | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Réanimation Chirurgicale | Angers | 49933 | France | |||
| Service de Réanimation Médicale - CH d'Angoulême |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34521664 | Result | 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. | |
| 37888914 |
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| Inhaled placebo | Drug | Once a day, inhaled placebo at day 4, day 5 and day 6 of invasive mechanical ventilation. |
|
| Clinical pulmonary infection score evolution | Patients will be followed from randomization to day 28 |
| Ventilator associated events incidence | Patients will be followed from randomization to day 28 |
| Number of systemic antibiotics administered per day | Patients will be followed from randomization to day 28 |
| Number of days with at least one administration of a systemic antibiotic | Patients will be followed from randomization to day 28 |
| Incidence of antibiotic resistant bacteria isolated on clinical and hygiene samples | Patients will be followed from randomization to day 28 |
| Incidence of acute kidney injury | Patients will be followed from randomization to day 28 |
| Days spent on mechanical ventilation from randomization to day 90 | Patients will be followed from randomization to day 90 |
| Days from randomization to the first successful spontaneous breathing trial | Days from randomization to day 90 max |
| Days spent in the intensive care unit and in the hospital | Patients will be followed from randomization to discharge (day 90 max) |
| Day 90 mortality | Day 90 |
| Incidence of bacteria producing extended spectrum beta-lactamase or high level derepressed celphalosporinase, of vancomycin resistant Enterococcus Sp. on rectal samples | Day 28 |
| Relative bacterial species composition of respiratory and digestive microbiota | Patients will be followed from randomization to day 28 |
| Maximum serum Concentration | Between Hour 0-Hour 8, between Hour 8-Hour 16 and between Hour 16-Hour 24 |
| Maximum sputum Concentration | Between Hour 0-Hour 8, between Hour 8-Hour 16 and between Hour 16-Hour 24 |
| Area Under the Curve | Between Hour 0-Hour 8, between Hour 8-Hour 16 and between Hour 16-Hour 24 |
| To evaluate the effects on respiratory mechanics of nebulization of amikacin by evaluating the benefit balance / risk | benefit : Improvement of respiratory mechanics by pharmacological effect risk : Degradation of respiratory mechanics by bronchospastic secondary effect, drug deposition in the intubation probe | Measurements at 8 hours, 12 hours and 24 hours after the end of nebulization |
| Angoulême |
| 16959 |
| France |
| Service de Réanimation Polyvalente | Argenteuil | France |
| Service de Réanimation Médicale - Hôpital Louis Mourier | Colombes | 92700 | France |
| Service de Réanimation | Dijon | 21079 | France |
| Service de Réanimation Médicale - CHD Les Oudairies | La Roche-sur-Yon | 85025 | France |
| Service de Réanimation | Le Mans | 72037 | France |
| Service de Réanimation Médicale - Hôpital La Croix-Rousse | Lyon | 69317 | France |
| Service de Réanimation Médicale | Orléans | 45100 | France |
| Service de Réanimation Médicale - Hôpital Pitié Salpêtrière | Paris | 75013 | France |
| Service de Réanimation Médicale - CHU La Milétrie | Poitiers | 86021 | France |
| Service de Réanimation Médicale | Poitiers | 86021 | France |
| Service de Réanimation Médicale - CHU Pontchaillou | Rennes | 35033 | France |
| Service de Réanimation Médicale - CHU Rouen | Rouen | 76031 | France |
| Service de Réanimation Médicale - Hôpital Charles Nicolle | Rouen | 76031 | France |
| Service de Réanimation - NHC | Strasbourg | 67091 | France |
| Service de Réanimation Médicale - Hôpital de Hautepierre | Strasbourg | 67098 | France |
| Service de Réanimation médicale, Hôpital Trousseau | Tours | 37044 | France |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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