Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorUniversity of Pisa

About this trial

* 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

lack of signed informed consent

lack of TDM for ACV

unavailable patient's demographic characteristics

Trial population

Patients aged 0-18 years, affected by hematological malignancies, undergoing ACV prophylaxis or treatment for HSV-VZV infection routinely during allogeneic HSCT or ACV treatment during high-intensity chemotherapy, for who a therapeutic drug monitoring (TDM) protocol is available. Patients receive ACV as a standard 1-h intravenous infusion or through the oral administration of valaciclovir

Trial design

Design model

Case-only

Time perspective

Retrospective

Treatments tested in this trial

  • Pharmacokinetic analysis

    Other intervention

    Population pharmacokinetic analysis of plasma concentrations of aciclovir obtained during routine therapeutic drug monitoring

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Intravenous Aciclovir1 intervention
Group B: Oral Aciclovir1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Six months since the beginning of acyclovir administration

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of Pisa

Lead sponsor

IRCCS Burlo Garofolo

Collaborator