- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Herpesvirus infections may lead to severe disease with a high risk of complications and mortality in hematopoietic stem cell transplant (HSCT) recipients, or in patients receiving high-intensity chemotherapy for hematological malignancies. That risk is mainly associated with the worldwide prevalence of herpes simplex virus 1 (HSV-1) that increases consistently with age. In particular, the majority of adult leukemia patients are HSV seropositive, while allogeneic HSCT recipients had post-transplant HSV reactivation. It is worth noting that in the first post-transplant year, symptomatic varicella-zoster virus (VZV) reactivation has a rate of 13% - 55% in adult recipients. Similar percentages of children receiving HSCT had VZV reactivation, being also possible a disseminated infection in 10% of children. However, thanks to antiviral prophylaxis in seropositive HSCT recipients, the rate of infection has significantly dropped.
Among the drugs most used for treatment and prophylaxis of HSV/VZV infections among children who are HSCT recipients or undergo a high-intensity chemotherapy, acyclovir represents the drug of choice. Although its role in preventing and treating herpes virus infections, the pharmacokinetics of acyclovir is highly variable, especially in patients in intensive care units, in those who have organ dysfunction, or in children. In particular, information about the optimal use of acyclovir in children with malignancies is limited.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Natalia Maximova, MD
- Phone Number: 565 040 378 5111
- Email: natalia-maximova@burlo.trieste.it
Study Locations
-
-
TS
-
Trieste, TS, Italy, 34137
- Recruiting
- IRCCS Burlo Garofolo, Bone Marrow Transplant Unit, Institute for Maternal and Child Health
-
Contact:
- Natalia Maximova, MD
- Email: natalia.maximova@burlo.trieste.it
-
Sub-Investigator:
- Antonello Di Paolo, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Intravenous Aciclovir
Patients receiving intravenous aciclovir for prophylaxis or treatment of herpes virus infections
|
Population pharmacokinetic analysis of plasma concentrations of aciclovir obtained during routine therapeutic drug monitoring
|
Oral Aciclovir
Patients receiving oral aciclovir/valaciclovir for prophylaxis or treatment of herpes virus infections
|
Population pharmacokinetic analysis of plasma concentrations of aciclovir obtained during routine therapeutic drug monitoring
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients who achieve an acyclovir minimum plasma concentration of 0.5 mg/L at steady state
Time Frame: Six months since the beginning of acyclovir administration
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Natalia Maximova, MD, IRCCS Burlo Garofolo
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC_10/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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