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NCT05198570

Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients

Recruiting now Last updated 4 June 2025
What this trial tests

trial testing Pharmacokinetic analysis in Herpesviridae Infections in 200 participants. Currently enrolling.

Timeline
15 September 2021
Primary endpoint
31 December 2025
31 March 2026

Quick facts

Lead sponsorUniversity of Pisa
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment200
Start date15 September 2021
Primary completion31 December 2025
Estimated completion31 March 2026
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

University of Pisa

Who can join

Adults 6 Months to 18, any sex, with Herpesviridae Infections or Herpes Simplex 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

* 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Population Pharmacokinetics of Intravenous Acyclovir in Oncologic Pediatric Patients.
    Maximova N, Nisticò D, Luci G, Simeone R, et al · · 2022 · cited 3× · PMID 35496277 · DOI 10.3389/fphar.2022.865871

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