[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644125":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":27,"locations":33,"responsibleParty":280,"collaborators":282,"id":286,"slug":287,"hasResults":288,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":288,"sex":294,"minAge":295,"maxAge":11,"enrollmentInfo":296,"targetDuration":11,"studyType":299,"phases":300,"briefSummary":302,"conditions":303,"keywords":306,"overallStatus":316,"whyStopped":11,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":326},{"fullName":5,"class":6},"University Hospital, Tours","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Inhaled amikacin","EXPERIMENTAL",null,[13],"Drug: Optimized and protocolized nebulization procedure.",{"label":15,"type":16,"description":11,"interventionNames":17},"Inhaled NaCl 0.9%","PLACEBO_COMPARATOR",[13],[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Optimized and protocolized nebulization procedure.","Patients in the experimental group will receive inhaled amikacin (once daily, 20 mg\u002Fkg 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).",[9],{"type":20,"name":21,"description":25,"armGroupLabels":26,"otherNames":11},"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).",[15],[28],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"François BARBIER, PU-PH","CONTACT","02 38 22 99 39","francois.barbier@chu-orleans.fr",[34,53,67,81,96,111,126,141,150,165,181,196,209,224,235,250,265],{"facility":35,"status":11,"city":36,"state":11,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"06 - ANGERS - Intensive care, University Hospital","Angers","49933","France","FR",{"type":41,"coordinates":42},"Point",[43,44],-0.55202,47.47156,{"lat":44,"lon":43},[47,51],{"name":48,"role":30,"phone":49,"phoneExt":11,"email":50},"Tchamba Achille KOUATCHET","02 41 35 38 15","AcKouatchet@chu-angers.fr",{"name":48,"role":52,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"facility":54,"status":11,"city":55,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"04 - ARGENTEUIL - Intensive care, University Hospital","Argenteuil",{"type":41,"coordinates":57},[58,59],2.24744,48.94788,{"lat":59,"lon":58},[62,66],{"name":63,"role":30,"phone":64,"phoneExt":11,"email":65},"Gaëtan PLANTEFEVE","01 34 23 14 45","gaetan.plantefeve@ch-argenteuil.fr",{"name":63,"role":52,"phone":11,"phoneExt":11,"email":11},{"facility":68,"status":11,"city":69,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"11 - BLOIS, Intensive care, Hospital","Blois",{"type":41,"coordinates":71},[72,73],1.32912,47.59432,{"lat":73,"lon":72},[76,80],{"name":77,"role":30,"phone":78,"phoneExt":11,"email":79},"Julien GROUILLE","02 54 55 60 73","grouilj@ch-blois.fr",{"name":77,"role":52,"phone":11,"phoneExt":11,"email":11},{"facility":82,"status":11,"city":83,"state":11,"zip":84,"country":38,"countryCode":39,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"09 - BOURG-EN-BRESSE, Intensive care, Hospital","Bourg-en-Bresse","01012",{"type":41,"coordinates":86},[87,88],5.2258,46.20574,{"lat":88,"lon":87},[91,95],{"name":92,"role":30,"phone":93,"phoneExt":11,"email":94},"Adrien ROBINE","04 74 45 46 47","arobine@ch-bourg01.fr",{"name":92,"role":52,"phone":11,"phoneExt":11,"email":11},{"facility":97,"status":11,"city":98,"state":11,"zip":99,"country":38,"countryCode":39,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"10 - HENRI MONDOR, Intensive care, University Hospital","Créteil","94010",{"type":41,"coordinates":101},[102,103],2.46569,48.79266,{"lat":103,"lon":102},[106,110],{"name":107,"role":30,"phone":108,"phoneExt":11,"email":109},"Pierre BAY","01 49 81 23 89","pierre.bay@aphp.fr",{"name":107,"role":52,"phone":11,"phoneExt":11,"email":11},{"facility":112,"status":11,"city":113,"state":11,"zip":114,"country":38,"countryCode":39,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"07 - DIEPPE - Intensive care, University Hospital","Dieppe","76202",{"type":41,"coordinates":116},[117,118],1.07772,49.9216,{"lat":118,"lon":117},[121,125],{"name":122,"role":30,"phone":123,"phoneExt":11,"email":124},"Pierre-Louis DECLERCQ","02 32 14 76 76","Pdeclercq@ch-dieppe.fr",{"name":122,"role":52,"phone":11,"phoneExt":11,"email":11},{"facility":127,"status":11,"city":128,"state":11,"zip":129,"country":38,"countryCode":39,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"08 - DIJON - Intensive care, University Hospital","Dijon","21000",{"type":41,"coordinates":131},[132,133],5.01391,47.31344,{"lat":133,"lon":132},[136,140],{"name":137,"role":30,"phone":138,"phoneExt":11,"email":139},"Jean-Pierre QUENOT","03 80 29 37 51","jean-pierre.quenot@chu-dijon.fr",{"name":137,"role":52,"phone":11,"phoneExt":11,"email":11},{"facility":142,"status":11,"city":143,"state":11,"zip":144,"country":38,"countryCode":39,"cosmosGeoPoint":145,"geoPoint":149,"contacts":11},"12 - DREUX, Intensive care, Hospital","Dreux","28100",{"type":41,"coordinates":146},[147,148],1.36566,48.73649,{"lat":148,"lon":147},{"facility":151,"status":11,"city":152,"state":11,"zip":153,"country":38,"countryCode":39,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"14 - VERSAILLES, Intensive care, Hospital","Le Chesnay","78150",{"type":41,"coordinates":155},[156,157],2.12213,48.8222,{"lat":157,"lon":156},[160,164],{"name":161,"role":30,"phone":162,"phoneExt":11,"email":163},"Alexis FERRE","01 39 63 87 00","aferre@ght78sud.fr",{"name":161,"role":52,"phone":11,"phoneExt":11,"email":11},{"facility":166,"status":11,"city":167,"state":11,"zip":168,"country":38,"countryCode":39,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"05 - LE MANS - Intensive care, University Hospital","Le Mans","72037",{"type":41,"coordinates":170},[171,172],0.20251,48.0021,{"lat":172,"lon":171},[175,179],{"name":176,"role":30,"phone":177,"phoneExt":11,"email":178},"Mickael LANDAIS, MD","02 43 43 24 58","mlandais@ch-lemans.fr",{"name":180,"role":52,"phone":11,"phoneExt":11,"email":11},"Mickaël LANDAIS",{"facility":182,"status":11,"city":183,"state":11,"zip":184,"country":38,"countryCode":39,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"15 - LYON EH, Intensive care, University Hospital","Lyon","69437",{"type":41,"coordinates":186},[187,188],4.84789,45.74906,{"lat":188,"lon":187},[191,195],{"name":192,"role":30,"phone":193,"phoneExt":11,"email":194},"Laurent ARGAUD","04 72 11 28 62","laurent.argaud@chu-lyon.fr",{"name":192,"role":52,"phone":11,"phoneExt":11,"email":11},{"facility":197,"status":11,"city":198,"state":11,"zip":199,"country":38,"countryCode":39,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"01 - ORLEANS - Intensive care, University Hospital","Orléans","45000",{"type":41,"coordinates":201},[202,203],1.90407,47.90248,{"lat":203,"lon":202},[206,208],{"name":207,"role":30,"phone":31,"phoneExt":11,"email":32},"François BARBIER",{"name":207,"role":52,"phone":11,"phoneExt":11,"email":11},{"facility":210,"status":11,"city":211,"state":11,"zip":212,"country":38,"countryCode":39,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"17 - LOUIS MOURIER, Intensive care, University Hospital","Paris","32700",{"type":41,"coordinates":214},[215,216],2.3488,48.85341,{"lat":216,"lon":215},[219,223],{"name":220,"role":30,"phone":221,"phoneExt":11,"email":222},"Damien ROUX","01 47 60 68 33","damien.roux@aphp.fr",{"name":220,"role":52,"phone":11,"phoneExt":11,"email":11},{"facility":225,"status":11,"city":211,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":226,"geoPoint":228,"contacts":229},"13 - BICHAT, Intensive care, Univerity Hospital",{"type":41,"coordinates":227},[215,216],{"lat":216,"lon":215},[230,234],{"name":231,"role":30,"phone":232,"phoneExt":11,"email":233},"Jean-François TIMSIT","01 40 25 77 03","jean-francois.timsit@aphp.fr",{"name":231,"role":52,"phone":11,"phoneExt":11,"email":11},{"facility":236,"status":11,"city":237,"state":11,"zip":238,"country":38,"countryCode":39,"cosmosGeoPoint":239,"geoPoint":243,"contacts":244},"16 - LYON SUD, Intensive care, University Hospital","Pierre-Bénite","69495",{"type":41,"coordinates":240},[241,242],4.82424,45.70359,{"lat":242,"lon":241},[245,249],{"name":246,"role":30,"phone":247,"phoneExt":11,"email":248},"Donatien DE MARIGNAN","04 78 86 21 19","donatien.de-marignan@chu-lyon.fr",{"name":246,"role":52,"phone":11,"phoneExt":11,"email":11},{"facility":251,"status":11,"city":252,"state":11,"zip":253,"country":38,"countryCode":39,"cosmosGeoPoint":254,"geoPoint":258,"contacts":259},"03 - STRASBOURG - Intensive care, University Hospital","Strasbourg","67091",{"type":41,"coordinates":255},[256,257],7.74553,48.58392,{"lat":257,"lon":256},[260,264],{"name":261,"role":30,"phone":262,"phoneExt":11,"email":263},"Julien DEMISELLE","03 69 55 10 19","julien.demiselle@chru-strasbourg.fr",{"name":261,"role":52,"phone":11,"phoneExt":11,"email":11},{"facility":266,"status":11,"city":267,"state":11,"zip":268,"country":38,"countryCode":39,"cosmosGeoPoint":269,"geoPoint":273,"contacts":274},"02 - TOURS - Intensive care, University Hospital","Tours","37044",{"type":41,"coordinates":270},[271,272],0.70398,47.39484,{"lat":272,"lon":271},[275,279],{"name":276,"role":30,"phone":277,"phoneExt":11,"email":278},"Stephan EHRMANN","02 47 47 98 51","stephan.ehrmann@univ-tours.fr",{"name":276,"role":52,"phone":11,"phoneExt":11,"email":11},{"type":281,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[283],{"name":284,"class":285},"Aerogen","INDUSTRY","100644125","phase-3-inhaled-amikacin-versus-placebo-in-patients-with-ventilator-associated-tracheobronchitis-100644125",false,"NCT07665788","Inhaled Amikacin Versus Placebo in Patients With Ventilator-associated Tracheobronchitis","A Multicentre, Double-blind, Randomized Controlled Trial of Inhaled Amikacin Versus Placebo in Critically Ill Patients With Ventilator-associated Tracheobronchitis","AMIVAT","Inclusion criteria:\n\n* Age ≥ 18 years\n* Admission to a participating intensive care unit (ICU)\n* Invasive mechanical ventilation \\> 48 hours\n* 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)\u002FmL or on bronchoalveolar lavage ≥10.4 CFU\u002FmL or on plugging telescopic catheter ≥10.3 CFU\u002FmL\n* Coverage by the French health insurance system (Social Security)\n* 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.\n* For woman of childbearing potential: negative pregnancy test result at the time of inclusion\n\nExclusion criteria:\n\n* Previous ventilator-associated pneumonia due to the pathogens responsible for ventilator-associated tracheobronchitis during the same ICU stay\n* On-going antimicrobial therapy fpr ventilator-associated pneumonia\n* Ventilator-associated tracheobronchitis due to pathogens with intrinsic amikacin resistance (e.g. Stenotrophomonas maltophilia)\n* On-going therapy with intravenous amikacin or another aminoglycoside\n* Acute kidney injury stage 2 or 3 of the Kidney Disease Improving Global Outcomes (KDIGO) classification and\u002For advanced chronic kidney failure (glomerular filtration rate \\\u003C30 mL\u002Fmin), except in patients under renal replacement therapy\n* Grade B or C cirrhosis (Child-Pugh classification)\n* Scheduled extubation within 24h\n* Prior tracheotomy\n* Administration of inhaled antibiotics within the 7 preceding days\n* Known hypersensitivity to amikacin, another aminoglycoside, or any of the excipients\n* Myasthenia gravis\n* Contraindication to nebulization\n* On-going treatment with ataluren\n* 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).\n* Moribund patient\n* End-of-life decision\n* Previous inclusion in the present study\n* Participation to another interventional study\n* Inability of the patient, or the person providing consent, to understand all aspects of the research\n* Patient being a relative of the investigator or a relative of someone from the team directly involved in the trial, including doctors and pharmacists","ALL","18 Years",{"count":297,"type":298},250,"ESTIMATED","INTERVENTIONAL",[301],"PHASE3","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.",[304,305],"Ventilator-Associated Pneumonia","Ventilator-Associated Tracheobronchitis",[307,308,309,310,311,312,313,314,315],"Ventilator-associated tracheobronchitis","Ventilator-associated pneumonia","Inhaled antimicrobial therapy","Mechanical ventilation","Hospital-acquired infection","Ventilator-associated lower respiratory tract infection","ICU-acquired infection","Aminoglycoside","Amikacin","NOT_YET_RECRUITING","2026-06-18",{"date":319,"type":320},"2026-06-24","ACTUAL",{"date":322,"type":298},"2026-06-01",{"date":324,"type":298},"2029-09-01",{"name":5,"class":6},17]