[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505363":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":35,"responsibleParty":142,"collaborators":144,"id":152,"slug":153,"hasResults":154,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":10,"eligibilityCriteria":157,"healthyVolunteers":154,"sex":158,"minAge":159,"maxAge":10,"enrollmentInfo":160,"targetDuration":10,"studyType":163,"phases":10,"briefSummary":164,"conditions":165,"keywords":168,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},{"fullName":5,"class":6},"University Hospital Ostrava","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Suspicion of IPA at enrolment",null,"Study subjects with suspicion of IPA at enrolment will be included in this study group.",[13],"Diagnostic Test: Next generation improvement of early invasive aspergillosis",{"label":15,"type":10,"description":16,"interventionNames":17},"Probable or proven IPA at enrolment","Study subjects with probable or proven IPA at enrolment will be included in this study group.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","Next generation improvement of early invasive aspergillosis","Next generation improvement of early invasive aspergillosis test is intended to determine the suitability of new potential biomarkers of aspergillosis.",[15,9],[25],{"name":26,"affiliation":5,"role":27},"Jozef Škarda, Assoc.Prof.,MD,DVM,PhD","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Jiří Hynčica","CONTACT","0042059737","2587","jiri.hyncica@fno.cz",[36,56,72,88,101,109,122],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":10,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Havířov Hospital","RECRUITING","Havířov","Moravian-Silesian Region","736 01","Czechia",{"type":44,"coordinates":45},"Point",[46,47],18.43688,49.77984,{"lat":47,"lon":46},[50,55],{"name":51,"role":31,"phone":52,"phoneExt":53,"email":54},"Robert Bocek, MD","0042059649","1834","robert.bocek@nemhav.cz",{"name":51,"role":27,"phone":10,"phoneExt":10,"email":10},{"facility":57,"status":38,"city":58,"state":40,"zip":59,"country":42,"countryCode":10,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Krnov Hospital","Krnov","794 01",{"type":44,"coordinates":61},[62,63],17.70385,50.08967,{"lat":63,"lon":62},[66,71],{"name":67,"role":31,"phone":68,"phoneExt":69,"email":70},"Zbyněk Vrba, MD","0042055469","0143","vrba.zbynek@szzkrnov.cz",{"name":67,"role":27,"phone":10,"phoneExt":10,"email":10},{"facility":73,"status":38,"city":74,"state":40,"zip":75,"country":42,"countryCode":10,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Public Health Institute Ostrava","Ostrava","702 00",{"type":44,"coordinates":77},[78,79],18.28204,49.83465,{"lat":79,"lon":78},[82,87],{"name":83,"role":31,"phone":84,"phoneExt":85,"email":86},"Radim Dobiáš, Mgr.,PhD","0042059620","0239","radim.dobias@zuova.cz",{"name":83,"role":27,"phone":10,"phoneExt":10,"email":10},{"facility":89,"status":38,"city":74,"state":40,"zip":90,"country":42,"countryCode":10,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"University of Ostrava","703 00",{"type":44,"coordinates":92},[78,79],{"lat":79,"lon":78},[95,100],{"name":96,"role":31,"phone":97,"phoneExt":98,"email":99},"Lenka Kramná, Mgr.,PhD","0042055346","1741","lenka.kramna@osu.cz",{"name":96,"role":27,"phone":10,"phoneExt":10,"email":10},{"facility":5,"status":38,"city":74,"state":40,"zip":102,"country":42,"countryCode":10,"cosmosGeoPoint":103,"geoPoint":105,"contacts":106},"708 52",{"type":44,"coordinates":104},[78,79],{"lat":79,"lon":78},[107,108],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},{"name":26,"role":27,"phone":10,"phoneExt":10,"email":10},{"facility":110,"status":38,"city":74,"state":40,"zip":111,"country":42,"countryCode":10,"cosmosGeoPoint":112,"geoPoint":114,"contacts":115},"Municipal Hospital Ostrava","728 80",{"type":44,"coordinates":113},[78,79],{"lat":79,"lon":78},[116,121],{"name":117,"role":31,"phone":118,"phoneExt":119,"email":120},"Štefan Kis Pisti, MD","0042059619","2656","aro@mnof.cz",{"name":117,"role":27,"phone":10,"phoneExt":10,"email":10},{"facility":123,"status":38,"city":124,"state":125,"zip":126,"country":42,"countryCode":10,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"University Hospital Olomouc","Olomouc","Olomouc Region","779 00",{"type":44,"coordinates":128},[129,130],17.25175,49.59552,{"lat":130,"lon":129},[133,138,139],{"name":134,"role":31,"phone":135,"phoneExt":136,"email":137},"Milan Raška, prof.,MD,PhD","0042058563","2751","milan.raska@upol.cz",{"name":134,"role":27,"phone":10,"phoneExt":10,"email":10},{"name":140,"role":141,"phone":10,"phoneExt":10,"email":10},"Vladimír Havlíček, prof.,Ing.,PhD","SUB_INVESTIGATOR",{"type":143,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[145,147,148,149,150,151],{"name":73,"class":146},"UNKNOWN",{"name":123,"class":6},{"name":110,"class":6},{"name":37,"class":146},{"name":57,"class":146},{"name":89,"class":6},"100505363","early-diagnosis-of-invasive-lung-aspergillosis-100505363",false,"NCT05860387","Early Diagnosis of Invasive Lung Aspergillosis","Inclusion Criteria:\n\n* respiratory rate ≥ 30 breaths\u002Fmin\n* PaO2\u002FFiO2 ratio ≤ 250\n* multilobar infiltrates\n* confusion\u002Fdisorientation\n* uremia (blood urea nitrogen level ≥ 20mg\u002FdL)\n* leucocytosis (white blood cell count \\> 12000\u002FmL) or\n* leukopenia (white blood cell count \\\u003C 4 x 109\u002FL)\n* thrombocytopenia (platelet count \\\u003C 100 x 109\u002FL)\n* hyperthermia (core temperature \\> 38 °C)\n* hypothermia (core temperature \\\u003C 36 °C)\n* hypotension requiring aggressive fluid resuscitation\n* invasive mechanical ventilation and septic shock requiring vasopressors\n* Bronchoalveolar Lavage Fluid (BALF) and\u002For Endotracheal Aspirate (ETA)\n\nExclusion Criteria:\n\n\\- patients, in whom PTX3, Aspergillus qPCR, and HPLC-FTICR were not performed or were performed after the start of antifungal treatment","ALL","18 Years",{"count":161,"type":162},150,"ESTIMATED","OBSERVATIONAL","The last decade has seen a significant increase in secondary Aspergillus infections, not only due to primary hypersensitivity, and immunodeficiency based on oncological diseases and their therapy, but mainly due to a rise in severe respiratory infections (H1N1, COVID-19, bacterial infections). This is most evident in critically ill patients whose life is threatened by invasive pulmonary aspergillosis (IPA), with over 90 % of cases being caused by Aspergillus fumigatus. In recent decades, various biomarkers with well-known limits of use (Aspergillus DNA, galactomannan, 1,3-ß-D-glucan) have been used for early diagnosis of IPA. However, the clinical need to clearly distinguish the onset of IPA from colonization is much more significant. The current biomarkers only provide \"probable IPA\" interpretation, and the diagnosis is rarely confirmed. Based on our preliminary studies, the use of new low molecular weight substances (secondary metabolites) combined with acute-phase proteins (pentraxin 3) allows very reliable immediate confirmation of IPA. In tissue samples, bronchoalveolar lavage fluid, endotracheal aspirate, breath condensate, serum, and urine of critically ill patients, the investigators will be able to recognize and confirm IPA in time using highly sensitive mass spectrometry detecting specific microbial siderophores in correlation with a significantly increased concentration of acute-phase host protein (pentraxin 3) within hours of the beginning of the invasion of lung tissue. Through a prospective multicentre study, the investigators will evaluate the benefit of new biomarkers in non-invasive IPA confirmation, improve the IPA diagnostic algorithm and transfer the detection method to MALDI-TOF spectrometers widely used in Clinical laboratories in the Czech Republic. In MALDI-TOF mass spectrometry, the ion source is matrix-assisted laser desorption\u002Fionization (MALDI), and the mass analyser is a time-of-flight (TOF) analyser.\n\nThe study results will contribute to a high clarity of IPA cases, the accurate introduction of antifungal therapy, and a better prognosis of survival of critically ill patients.",[166,167],"Respiratory Infection","Invasive Pulmonary Aspergillosis",[169,170,171,172,173,174,175],"biomarkers","qualitative polymerase chain reaction (qPCR)","metallomics","mass spectrometry","colonisation","invasive pulmonary aspergillosis","Pentraxin-3","2023-09-06",{"date":178,"type":179},"2023-09-07","ACTUAL",{"date":181,"type":179},"2023-05-31",{"date":183,"type":162},"2026-12-31",{"name":5,"class":6},7]