[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ventilator-associated-tracheobronchitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ventilator-associated-tracheobronchitis":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"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":20,"type":21},250,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Ventilator-Associated Pneumonia","Ventilator-Associated Tracheobronchitis",[30,31,32,33,34,35,36,37,38],"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":42,"type":43},"2026-06-24","ACTUAL",{"date":45,"type":21},"2026-06-01",{"date":47,"type":21},"2029-09-01",{"name":49,"class":50},"University Hospital, Tours","OTHER",17,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100459703","ventilator-associated-tracheobronchitis-initiative-to-conduct-antibiotic-evaluation-100459703","NCT05266066","Ventilator-associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation","Multicenter Randomized Clinical Trial of Antimicrobial Treatment in Ventilator-associated Tracheobronchitis","VATICAN","Inclusion Criteria:\n\n* Admission to one of the participating ICUs\n* Invasive Mechanical ventilation ≥ 48 hours\n* Available chest imaging of screening day\n* Clinical diagnosis of VAT, defined by the presence of:\n\n  1. Temperature \\>38.0°C or \\\u003C36°C OR leukocytes \\>12000\u002FmL or \\\u003C4000\u002FmL or presence \\>10% of immature forms, AND\n  2. Onset of purulent tracheal secretion, or change in characteristics of the secretion, or increase in the amount of respiratory secretion, or increased need for aspiration\n* Culture of tracheal secretion from the day of screening under analysis or collected for analysis\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Indication of use of antibiotics or use of systemic antibiotics for any indications at the time of screening\n* Hemodynamic instability, defined as hypotension unresponsive to volume expansion or increase in vasopressor dose \\> 0.1mcg\u002Fkg\u002Fmin of noradrenaline or equivalent in the past 6 hours\n* Worsening of gas exchange, defined as an increase in the fraction of inspired oxygen ≥ 20% or an increase in positive end-expiratory pressure (PEEP) ≥ 3 cm of water after a stability period ≥ 2 days\n* Prolonged mechanical ventilation, defined by use of invasive mechanical ventilation for 21 days or more\n* Presence of pulmonary radiological image suggestive of new infectious infiltrate\n* Previous lung disease that makes radiological interpretation for the diagnosis of VAP difficult\n* Previous diagnosis of ventilator associates pneumonia (VAP) during hospitalization\n* Neutropenic patients (neutrophils \\\u003C1000\u002FmL)\n* Known severe immunosuppression\n* Tracheostomized patients at the time of screening\n* Inclusion in the study in the past 30 days\n* Expected limitation of care or early withdrawal of supportive therapies (\\\u003C 7 days)\n* Patients with a survival expectancy of less than 48 hours\n* Refusal of consent to participate in the study",{"count":61,"type":21},590,[63],"NA","The Ventilator Associated tracheobronchitis Initiative to Conduct Antibiotic evaluation (VATICAN) trial is a national, multicenter, non-inferiority trial in ICU patients comparing antibiotic treatment for 7 days versus clinical observation without antibiotic treatment for patients with ventilator-associated tracheobronchitis.",[66,67],"Ventilator Associated Tracheobronchitis","Tracheobronchitis",[69,70,33,71],"Antibiotics","Ventilator associated Tracheobronchitis","Critically ill","RECRUITING","2025-06-16",{"date":75,"type":43},"2025-06-19",{"date":77,"type":43},"2022-07-11",{"date":79,"type":21},"2026-12-01",{"name":81,"class":50},"Hospital Sirio-Libanes",16]