[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100164968":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":37,"responsibleParty":58,"collaborators":10,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":10,"eligibilityCriteria":65,"healthyVolunteers":62,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Posaconazole oral suspension",null,"One group of patients will receive posaconazole oral suspension as prophylactic agent.\n\nBlood sampling: At day of transplantation, day 7 and 14, 9 blood samples will be collected to calculate AUC. Moreover, citrulline will be determined to objectively evaluate the severity of mucositis.",[13],"Procedure: blood sampling",{"label":15,"type":10,"description":16,"interventionNames":17},"Posaconazole oral tablet","Once the oral tablet is available for adminstration to patients, a second group of patients will receive these tablets as prophylactic agent.\n\nBlood sampling: At day of transplantation, day 7 and 14, 9 blood samples will be collected to calculate AUC. Moreover, citrulline will be determined to objectively evaluate the severity of mucositis.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"PROCEDURE","blood sampling","During posaconazole treatment, blood sampling will occur on day 0 (=day of transplantation), day 7 and 14 to correlate posaconazole exposure to severity of mucositis.",[9,15],[25],{"name":26,"affiliation":27,"role":28},"Kim Vanstraelen, R.Ph.","Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy","PRINCIPAL_INVESTIGATOR",[30,34],{"name":26,"role":31,"phone":32,"phoneExt":10,"email":33},"CONTACT","(+32) (0)16342339","kim.vanstraelen@uzleuven.be",{"name":35,"role":31,"phone":10,"phoneExt":10,"email":36},"Isabel Spriet, Pharm.D.","isabel.spriet@uzleuven.be",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"University Hospitals Leuven","RECRUITING","Leuven","Vlaams-Brabant","3000","Belgium","BE",{"type":47,"coordinates":48},"Point",[49,50],4.70093,50.87959,{"lat":50,"lon":49},[53,54,56],{"name":26,"role":28,"phone":10,"phoneExt":10,"email":10},{"name":35,"role":55,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"name":57,"role":55,"phone":10,"phoneExt":10,"email":10},"Ludo Willems, Professor",{"type":59,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100164968","pharmacokinetics-of-posaconazole-in-allogeneic-transplant-patients-with-mucositis-100164968",false,"NCT01420562","Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis","Inclusion Criteria:\n\n* Patients receiving allogeneic stem cell transplantation - Treated with prophylactic posaconazole: oral suspension (200mg three times daily) or tablet (300mg once daily) to prevent invasive fungal infections\n\nExclusion Criteria:\n\n* Gastroparesis\n* Vomiting or diarrhea within 2 hours after intake of posaconazole\n* Concomitant administration of potent inducers of the enzyme UGT1A4: carbamazepine,phenytoin, phenobarbital, rifabutin, rifampicin,...\n* Age under 18 years","ALL","18 Years","75 Years",{"count":70,"type":71},55,"ESTIMATED","OBSERVATIONAL","The goal of this study is to calculate pharmacokinetic parameters and to evaluate the trough levels of posaconazole reached in patients with different stages of mucositis, due to chemotherapy and total body irradiation.",[75],"Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)",[77,78,79,80,81],"allogeneic HSCT","posaconazole","prophylaxis","mucositis","pharmacokinetics","2024-07-12",{"date":84,"type":85},"2024-07-15","ACTUAL",{"date":87,"type":10},"2011-09",{"date":89,"type":71},"2025-03",{"name":5,"class":6},1]