Understanding how intravenous acyclovir works in children with cancer
Pharmacokinetics of Intravenous Acyclovir in Children Undergoing Hematopoietic Stem Cell Transplantation or High-intensity Antineoplastic Chemotherapy
This study is trying to understand how the drug acyclovir works in children with cancer to see if it can help protect them from serious herpesvirus infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 6 Months to 18 Years |
| Sex | All |
| Sponsor | University of Pisa Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Trieste, TS) |
| Trial ID | NCT05198570 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the pharmacokinetics of intravenous acyclovir in pediatric patients with hematological malignancies or those undergoing hematopoietic stem cell transplantation. It aims to analyze how the drug behaves in the body, particularly in children, who may experience significant variability in drug metabolism. By monitoring drug levels and optimizing treatment protocols, the study seeks to improve outcomes for children at high risk of herpesvirus infections. The research is crucial for tailoring acyclovir therapy to enhance its effectiveness and safety in vulnerable pediatric populations.
Who should consider this trial
Good fit: Ideal candidates include children with hematological malignancies or those receiving HSCT who require acyclovir for herpesvirus infection prophylaxis or treatment.
Not a fit: Patients who do not require acyclovir treatment or those without hematological malignancies or HSCT are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and safer acyclovir dosing strategies for children with cancer, reducing the risk of herpesvirus infections.
How similar studies have performed: While the pharmacokinetics of acyclovir has been studied in adults, this specific focus on pediatric patients with malignancies is relatively novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Trieste, TS
- IRCCS Burlo Garofolo, Bone Marrow Transplant Unit, Institute for Maternal and Child Health — Trieste, Ts, Italy (Recruiting)
Study contacts
- Principal investigator: Natalia Maximova, MD — IRCCS Burlo Garofolo
- Study coordinator: Natalia Maximova, MD
- Email: natalia-maximova@burlo.trieste.it
- Phone: 040 378 5111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.