NCT05198570Recruiting
Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients
Pharmacokinetics of Intravenous Acyclovir in Children Undergoing Hematopoietic Stem Cell Transplantation or High-intensity Antineoplastic Chemotherapy
Source: ClinicalTrials.gov · Last updated 4 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
* 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 (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 4 Jan 2022
- Start date
- 15 Sept 2021
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of Pisa
- Diseases
- Childhood cancers
- NCT number
- NCT05198570
What you commit to
- Study type: Observational
- Planned participants: 200
- From 15 Sept 2021 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- lack of signed informed consent
- lack of TDM for ACV
- unavailable patient's demographic characteristics
Who the study is looking for
- 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
Age in the registry: 6 months to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Burlo Garofolo, Bone Marrow Transplant Unit, Institute for Maternal and Child Health Coordinator of this site? Confirm its status | Trieste | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.