RecruitingACTRN12622000645752

Modeling of pharmacokinetics of ganciclovir

Pharmacokinetics of ganciclovir by lung transplantation patients


Sponsor

Motol University Hospital

Enrollment

50 participants

Start Date

Jul 1, 2021

Study Type

Observational

Conditions

Summary

The aim of this prospective study was to evaluate the pharmacokinetics of ganciclovir in lung transplant recipients and to explore its covariates and propose an individualized ganciclovir dosing regimen.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 99 Yearss

Plain Language Summary

Simplified for easier understanding

Lung transplantation is a life-saving surgery for people with severe lung diseases such as cystic fibrosis, pulmonary fibrosis, or chronic obstructive pulmonary disease. After transplantation, recipients take an antiviral medicine called ganciclovir intravenously to prevent serious viral infections (particularly cytomegalovirus) which can threaten the transplanted lung. However, the right dose of ganciclovir varies between individuals depending on how their kidneys process the drug. This study examines the pharmacokinetics of ganciclovir — how the drug moves through the body over time — in lung transplant recipients, to understand what factors influence drug levels and to develop a more personalised dosing approach. Better dosing means more effective viral prevention with fewer side effects. You may be eligible if you have undergone a lung transplant and have been receiving intravenous ganciclovir twice daily for at least 48 hours after your transplant. Those with incomplete medical records are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Lung transplant patients receiving intravenous ganciclovir (5 mg/kg) twice daily for at least 48 hours after transplantation, blood samples will be collected and ganciclovir levels in the blood will b

Lung transplant patients receiving intravenous ganciclovir (5 mg/kg) twice daily for at least 48 hours after transplantation, blood samples will be collected and ganciclovir levels in the blood will be measured, The duration and frequency of observation in participants, 3-times for the first 24 hours and then in the sixth month post lung-transplant


Locations(1)

Prague, Czech Republic

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