[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100459703":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":40,"responsibleParty":224,"collaborators":226,"id":241,"slug":242,"hasResults":243,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":243,"sex":249,"minAge":250,"maxAge":24,"enrollmentInfo":251,"targetDuration":24,"studyType":254,"phases":255,"briefSummary":257,"conditions":258,"keywords":261,"overallStatus":43,"whyStopped":24,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":275},{"fullName":5,"class":6},"Hospital Sirio-Libanes","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Clinical observation without antibiotic therapy for VAT","EXPERIMENTAL","Patients will receive standard care and no antibiotic therapy for VAT. Antibiotics will be prescribed if other infections and\u002For organ dysfunction ensues (especially shock) or there is progression to pneumonia",[13],"Other: Clinical observation without antibiotic therapy for VAT",{"label":15,"type":16,"description":17,"interventionNames":18},"7 day antibiotic course for VAT","ACTIVE_COMPARATOR","Patients will receive standard care and 7 day course of antibiotic therapy for VAT.",[19],"Other: 7 day antibiotic course for VAT",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"Patients will receive standard care plus antibiotic if new organ dysfunction or new infections other than VAT.",[9],null,{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Patients will receive standard care plus 7 day course of antibiotic.",[15],[29],{"name":30,"affiliation":5,"role":31},"Bruno M Tomazini, 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Limeira","Limeira",{"type":49,"coordinates":177},[178,179],-47.40167,-22.56472,{"lat":179,"lon":178},[182],{"name":183,"role":34,"phone":24,"phoneExt":24,"email":24},"Luis Paciencia, MD",{"facility":185,"status":43,"city":186,"state":164,"zip":24,"country":46,"countryCode":47,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"Hospital Estadual Mario Covas","Santo André",{"type":49,"coordinates":188},[189,190],-46.53833,-23.66389,{"lat":190,"lon":189},[193],{"name":194,"role":34,"phone":24,"phoneExt":24,"email":24},"Caio Dernandes, MD",{"facility":196,"status":43,"city":164,"state":164,"zip":24,"country":46,"countryCode":47,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Hospital Samaritano",{"type":49,"coordinates":198},[199,200],-46.63611,-23.5475,{"lat":200,"lon":199},[203],{"name":204,"role":34,"phone":24,"phoneExt":24,"email":24},"Livia Melro, 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Vento",{"name":234,"class":6},"Hospital Alemão Oswaldo Cruz",{"name":236,"class":237},"BP - A Beneficência Portuguesa de São Paulo","UNKNOWN",{"name":239,"class":240},"Brazilian Research In Intensive Care Network","NETWORK","100459703","ventilator-associated-tracheobronchitis-initiative-to-conduct-antibiotic-evaluation-100459703",false,"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","ALL","18 Years",{"count":252,"type":253},590,"ESTIMATED","INTERVENTIONAL",[256],"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.",[259,260],"Ventilator Associated Tracheobronchitis","Tracheobronchitis",[262,263,264,265],"Antibiotics","Ventilator associated Tracheobronchitis","Mechanical ventilation","Critically ill","2025-06-16",{"date":268,"type":269},"2025-06-19","ACTUAL",{"date":271,"type":269},"2022-07-11",{"date":273,"type":253},"2026-12-01",{"name":5,"class":6},16]