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Search / Trial NCT05198570

Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients

Launched by UNIVERSITY OF PISA · Jan 19, 2022

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Hematopoietic Stem Cell Transplantation Herpes Virus Infections Aciclovir Children Pharmacokinetics

ClinConnect Summary

This clinical trial is studying how the body processes a medication called acyclovir (ACV) in children and young adults who are being treated for certain cancers or have received a stem cell transplant. Acyclovir is important for preventing and treating infections caused by herpes viruses, which can be very serious in patients with weakened immune systems. The trial aims to understand how to use this medication more effectively by closely monitoring how it works in different patients, particularly because children's bodies can respond differently to the drug than adults.

To be eligible for this trial, participants must be children or young adults aged 6 months to 24 years who have specific blood cancers, are receiving a stem cell transplant, or are undergoing strong chemotherapy treatments. They will need to have their parents sign consent forms to participate. Throughout the trial, participants will receive acyclovir either through an injection or by mouth and will be closely monitored to ensure the medication is working well for them. This research could help doctors better understand how to treat herpes infections in young cancer patients, ultimately improving their care and outcomes.

Gender

ALL

Eligibility 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

About University Of Pisa

The University of Pisa is a prestigious academic institution renowned for its commitment to advancing scientific research and education. With a rich history dating back to the 12th century, the university is dedicated to fostering innovation and excellence in various fields, including medicine and health sciences. As a clinical trial sponsor, the University of Pisa leverages its robust research infrastructure and interdisciplinary expertise to conduct rigorous clinical studies aimed at improving patient outcomes and contributing to the body of medical knowledge. Its collaborative approach involves partnerships with healthcare institutions and industry stakeholders, ensuring that research is aligned with the highest ethical standards and regulatory compliance.

Locations

Trieste, Ts, Italy

Patients applied

0 patients applied

Trial Officials

Natalia Maximova, MD

Principal Investigator

IRCCS Burlo Garofolo

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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