[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560825":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":47,"collaborators":19,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":19,"enrollmentInfo":59,"targetDuration":19,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":74,"whyStopped":19,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"University Hospital, Grenoble","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"individualized maintenance doses","EXPERIMENTAL","Individualization of first maintenance doses through a multiparametric algorithm integrating CYP2C19 genotype, C reactive protein level and age",[13],"Drug: Individualization of first voriconazole maintenance doses",[15],{"type":16,"name":17,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Individualization of first voriconazole maintenance doses",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Gautier-Veyret Elodie","Grenoble Alps University Hospital","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Gautier-Veyret Elodie, PharmD, PhD","CONTACT","+33476765492","Egautier@chu-grenoble.fr",{"name":32,"role":28,"phone":19,"phoneExt":19,"email":33},"Thiebaut-bertrand Anne, MD","Athiebaut@chu-grenoble.fr",[35],{"facility":36,"status":19,"city":37,"state":19,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":19},"Gautier-Veyret","Grenoble","38043","France","FR",{"type":42,"coordinates":43},"Point",[44,45],5.71479,45.17869,{"lat":45,"lon":44},{"type":48,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100560825","phase-4-individualized-first-maintenance-doses-of-voriconazole-through-a-multiparametric-algorithm-100560825",false,"NCT06582186","Individualized First Maintenance Doses of Voriconazole Through a Multiparametric Algorithm","Individualization of First Maintenance Doses of Voriconazole Using a Multiparametric Algorithm in Hematology Patients: a Prospective Single-arm Interventional Study","VORIPRECI","Inclusion Criteria:\n\n* adult patient suffering from haematological malignancy\n* followed in the clinical hematology department or in the hematology day hospital of the Grenoble Alps University Hospital\n* consenting to carrying out CYP2C19 genotyping\n* likely to start treatment with voriconazole (for curative or prophylactic purposes as part of care)\n* having signed a written consent to participate\n* affiliated to a social security system\n\nExclusion Criteria:\n\n* comedication with strong inhibitors\u002Finducers (valproic acid, phenytoin, carbamazepine, rifampicin)\n* Subject during exclusion period from another study,\n* Persons referred to in articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant woman, parturient woman, breastfeeding mother, person deprived of liberty by judicial or administrative decision, persons subject to care psychiatric pursuant to articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of article L. 1121-8, persons admitted to a health or social establishment for purposes other than research , minors, person subject to a legal protection measure or unable to express their consent)","ALL","18 Years",{"count":60,"type":61},30,"ESTIMATED","INTERVENTIONAL",[64],"PHASE4","The goal of this interventional single-arm study is to evaluate the interest of a multiparametric algorithm for individualization of first voriconazole maintenance doses for improvement of initial voriconazole exposure in adult patients with haematological malignancies. The main objective it aims is to determine the percentage of patients with initial voriconazole trough concentrations in the therapeutic range after individualization of first maintenance doses.\n\nParticipants will benefited from individualization of first voriconazole maintenance doses through a previously developed and validated multiparametric algorithm (publication in progress) taking into account CYP2C19 genotype, C reactive protein level and age.",[67,68,69],"Aspergillosis Invasive","Fungal Infection","Hematologic Malignancy",[71,72,73],"model-informed precision dosing","single-arm prospective interventional study","Simon design","NOT_YET_RECRUITING","2024-08-29",{"date":77,"type":78},"2024-09-03","ACTUAL",{"date":80,"type":61},"2024-10",{"date":82,"type":61},"2027-10",{"name":5,"class":6},1]