Oncology Clinical Trial
Official title:
Pharmacokinetics of Intravenous Acyclovir in Children Undergoing Hematopoietic Stem Cell Transplantation or High-intensity Antineoplastic Chemotherapy
NCT number | NCT05198570 |
Other study ID # | RC_10/20 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 15, 2021 |
Est. completion date | March 31, 2024 |
- Herpesvirus infections may be severe in immunocompromised patients, with a high risk of complications and mortality. - Recipients of hematopoietic stem cell transplant (HSCT) or patients receiving high-intensity chemotherapy for hematological malignancies are the most vulnerable individuals. - 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. - Acyclovir (ACV) is the first-choice drug for the prophylaxis or the therapy of that kind of infection. - Since the beginning, ACV has demonstrated to be characterized by a large interpatient variability, especially in children. - Therefore, therapeutic drug monitoring and pharmacokinetic studies may help in optimizing drug in children with malignancies.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | March 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 18 Years |
Eligibility | Inclusion Criteria: - Patients with Hematological malignancies - HSCT recipients who require ACV prophylaxis or treatment for HSV-VZV infection or - Children undergoing high-intensity antineoplastic chemotherapy who need ACV treatment. - Intravenous or oral ACV dosing - Active/available a therapeutic drug monitoring (TDM) protocol for ACV - Informed consent signed by patient's parents Exclusion Criteria: - lack of signed informed consent - lack of TDM for ACV - unavailable patient's demographic characteristics |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Burlo Garofolo, Bone Marrow Transplant Unit, Institute for Maternal and Child Health | Trieste | TS |
Lead Sponsor | Collaborator |
---|---|
University of Pisa | IRCCS Burlo Garofolo |
Italy,
Maximova N, Nistico D, Luci G, Simeone R, Piscianz E, Segat L, Barbi E, Di Paolo A. Population Pharmacokinetics of Intravenous Acyclovir in Oncologic Pediatric Patients. Front Pharmacol. 2022 Apr 14;13:865871. doi: 10.3389/fphar.2022.865871. eCollection 2 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients who achieve an acyclovir minimum plasma concentration of 0.5 mg/L at steady state | Percentage of patients who achieve an acyclovir minimum plasma concentration at steady state =0.5 mg/L, considered as an effective plasma concentration | Six months since the beginning of acyclovir administration |
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