[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100454517":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":28,"locations":34,"responsibleParty":54,"collaborators":57,"id":59,"slug":10,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":10,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":79,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University of Pisa","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intravenous Aciclovir",null,"Patients receiving intravenous aciclovir for prophylaxis or treatment of herpes virus infections",[13],"Other: Pharmacokinetic analysis",{"label":15,"type":10,"description":16,"interventionNames":17},"Oral Aciclovir","Patients receiving oral aciclovir\u002Fvalaciclovir for prophylaxis or treatment of herpes virus infections",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"Pharmacokinetic analysis","Population pharmacokinetic analysis of plasma concentrations of aciclovir obtained during routine therapeutic drug monitoring",[9,15],[24],{"name":25,"affiliation":26,"role":27},"Natalia Maximova, MD","IRCCS Burlo Garofolo","PRINCIPAL_INVESTIGATOR",[29],{"name":25,"role":30,"phone":31,"phoneExt":32,"email":33},"CONTACT","040 378 5111","565","natalia-maximova@burlo.trieste.it",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"IRCCS Burlo Garofolo, Bone Marrow Transplant Unit, Institute for Maternal and Child Health","RECRUITING","Trieste","TS","34137","Italy",{"type":43,"coordinates":44},"Point",[45,46],13.77678,45.64953,{"lat":46,"lon":45},[49,51],{"name":25,"role":30,"phone":10,"phoneExt":10,"email":50},"natalia.maximova@burlo.trieste.it",{"name":52,"role":53,"phone":10,"phoneExt":10,"email":10},"Antonello Di Paolo, MD","SUB_INVESTIGATOR",{"type":27,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Antonello Di Paolo, M.D., Ph.D.","Associate Professor of Pharmacology",[58],{"name":26,"class":6},"100454517",false,"NCT05198570","Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients","Pharmacokinetics of Intravenous Acyclovir in Children Undergoing Hematopoietic Stem Cell Transplantation or High-intensity Antineoplastic Chemotherapy","Inclusion Criteria:\n\n* Patients with Hematological malignancies\n* HSCT recipients who require ACV prophylaxis or treatment for HSV-VZV infection or\n* Children undergoing high-intensity antineoplastic chemotherapy who need ACV treatment.\n* Intravenous or oral ACV dosing\n* Active\u002Favailable a therapeutic drug monitoring (TDM) protocol for ACV\n* Informed consent signed by patient's parents\n\nExclusion Criteria:\n\n* lack of signed informed consent\n* lack of TDM for ACV\n* unavailable patient's demographic characteristics","ALL","6 Months","18 Years",{"count":69,"type":70},200,"ESTIMATED","OBSERVATIONAL","* Herpesvirus infections may be severe in immunocompromised patients, with a high risk of complications and mortality.\n* Recipients of hematopoietic stem cell transplant (HSCT) or patients receiving high-intensity chemotherapy for hematological malignancies are the most vulnerable individuals.\n* Although the worldwide prevalence of herpes simplex virus 1 (HSV-1) and varicella-zoster virus (VZV), antiviral prophylaxis in seropositive HSCT recipients has significantly reduced the rate of infection.\n* Acyclovir (ACV) is the first-choice drug for the prophylaxis or the therapy of that kind of infection.\n* Since the beginning, ACV has demonstrated to be characterized by a large interpatient variability, especially in children.\n* Therefore, therapeutic drug monitoring and pharmacokinetic studies may help in optimizing drug in children with malignancies.",[74,75,76,77,78],"Herpesviridae Infections","Herpes Simplex 1","Varicella Zoster Virus Infection","Transplantation Infection","Oncology",[80,81,82,83,84],"Hematopoietic stem cell transplantation","Herpes virus infections","Aciclovir","Children","Pharmacokinetics","2025-06-02",{"date":87,"type":88},"2025-06-04","ACTUAL",{"date":90,"type":88},"2021-09-15",{"date":92,"type":70},"2026-03-31",{"name":5,"class":6},1]