[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512453":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":42,"centralContacts":50,"locations":55,"responsibleParty":112,"collaborators":114,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":119,"sex":125,"minAge":126,"maxAge":28,"enrollmentInfo":127,"targetDuration":28,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":28,"overallStatus":98,"whyStopped":28,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Film-array Pneumonia Panel Plus group","EXPERIMENTAL","Patients with suspected HAP or VAP in which lower tract respiratory samples are analyzed with new multiplex PCR assay (Film-array Pneumonia Panel Plus)",[13,14,15,16],"Procedure: Lower tract respiratory samples","Diagnostic Test: Multiplex PCR assay (Film-array Pneumonia Panel Plus)","Diagnostic Test: Lower respiratory tract standard culture","Diagnostic Test: Blood sample standard culture",{"label":18,"type":19,"description":20,"interventionNames":21},"Standard culture group (control group)","ACTIVE_COMPARATOR","Patients with suspected HAP or VAP in which lower tract respiratory samples are analyzed with standard culture",[13,15,16],[23,29,34,38],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"PROCEDURE","Lower tract respiratory samples","Within 1 hour from HAP or VAP suspicion, quantitative tracheal aspirate or bronchoalveolar lavage will be performed to confirm the diagnosis. Clinicians will be encouraged to perform BAL whenever possible",[9,18],null,{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":28},"DIAGNOSTIC_TEST","Multiplex PCR assay (Film-array Pneumonia Panel Plus)","The lower tract respiratory samples will be analyzed with Multiplex PCR assay (Film-array Pneumonia Plus).",[9],{"type":30,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"Lower respiratory tract standard culture","The lower tract respiratory samples will be analyzed using convention microbiological methods (including conventional Gram stain and semiquantitative culture on both selective\u002Fdifferential and screening agar media)",[9,18],{"type":30,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"Blood sample standard culture","When HAP or VAP are suspected, blood samples from peripheral vein will be collected and analyzed with conventional microbiological methods",[9,18],[43,47],{"name":44,"affiliation":45,"role":46},"Gennaro De Pascale, MD","Fondazione Policlinico A. Gemelli IRCCS","PRINCIPAL_INVESTIGATOR",{"name":48,"affiliation":45,"role":49},"Massimo Antonelli, MD","STUDY_CHAIR",[51],{"name":44,"role":52,"phone":53,"phoneExt":28,"email":54},"CONTACT","+393208998173","gennaro.depascale@policlinicogemelli.it",[56,72,84,96],{"facility":57,"status":58,"city":59,"state":28,"zip":28,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"S. Orsola Research Hospital","NOT_YET_RECRUITING","Bologna","Italy","IT",{"type":63,"coordinates":64},"Point",[65,66],11.33875,44.49381,{"lat":66,"lon":65},[69],{"name":70,"role":52,"phone":28,"phoneExt":28,"email":71},"Tommaso Tonetti, MD","tommaso.tonetti@unibo.it",{"facility":73,"status":58,"city":74,"state":28,"zip":28,"country":60,"countryCode":61,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Ospedale Careggi","Florence",{"type":63,"coordinates":76},[77,78],11.24626,43.77925,{"lat":78,"lon":77},[81],{"name":82,"role":52,"phone":28,"phoneExt":28,"email":83},"Bruno Viaggi, MD","bruno.viaggi@gmail.com",{"facility":85,"status":58,"city":86,"state":28,"zip":28,"country":60,"countryCode":61,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Modena Policlinico","Modena",{"type":63,"coordinates":88},[89,90],10.92539,44.64783,{"lat":90,"lon":89},[93],{"name":94,"role":52,"phone":28,"phoneExt":28,"email":95},"Massimo Girardis, MD","girardis@unimore.it",{"facility":97,"status":98,"city":99,"state":28,"zip":100,"country":60,"countryCode":61,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Fondazione Policlinico Universitario \"A. GEMELLI\" IRCCS","RECRUITING","Roma","00168",{"type":63,"coordinates":102},[103,104],11.10642,44.99364,{"lat":104,"lon":103},[107,109],{"name":44,"role":52,"phone":28,"phoneExt":28,"email":108},"gennaro.depascalemd@gmail.com",{"name":110,"role":52,"phone":28,"phoneExt":28,"email":111},"Eloisa S Tanzarella, MD","eloisasofia.tanzarella@policlinicogemelli.it",{"type":113,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[115],{"name":116,"class":6},"Catholic University of the Sacred Heart","100512453","hapvap-diagnosis-in-critically-ill-septic-patients-using-a-multiplex-pcr-array-100512453",false,"NCT05952648","HAP\u002FVAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array","HAP\u002FVAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Assay: A Multicenter Randomized Open-Label Trial. THE LIGHTNING STUDY","LIGHTNING","Inclusion Criteria:\n\n* Suspicion of HAP\u002FVAP (clinical\u002Fradiological\u002Flaboratory criteria);\n* Availability to perform tracheal aspirates or broncoalveolar lavage within 1 hour from clinical suspicion\n* Life expectancy ≥ 48 hours\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Pregnancy,\n* Concomitant participating in other interventional trial\n* Refusal to sign informed consent","ALL","18 Years",{"count":128,"type":129},126,"ESTIMATED","INTERVENTIONAL",[132],"NA","Multicenter, randomized, controlled, open-label trial to assess if semiquantitative multiplex PCR assay, as compared to conventional microbiology, can reduce the percentage of patients without microbiological diagnosis in the first 24 hours from HAP\u002FVAP suspicion, thus allowing early de-escalation.",[135,136],"HAP - Hospital Acquired Pneumonia","VAP - Ventilator Associated Pneumonia","2025-08-11",{"date":139,"type":140},"2025-08-14","ACTUAL",{"date":142,"type":140},"2024-04-03",{"date":144,"type":129},"2026-04-01",{"name":5,"class":6},4]