Cytomegalovirus Infections Clinical Trial
Official title:
(Val)Ganciclovir Therapeutic Drug Monitoring in Transplant Recipients
The aim of this study is to gain more insight into therapeutic drug monitoring and thus the pharmacodynamics and pharmacokinetics of ganciclovir, in the context of prophylaxis and treatment of CMV infections, in order to provide the patient with an adequate dose.
Patients undergoing solid organ or stem cell transplantation are at risk of developing
cytomegalovirus (CMV) infection or reactivation. The risk of CMV infection / reactivation and
its severity depends on the CMV serostatus of donor and recipient. Valganciclovir (oral
pro-drug of ganciclovir) prophylaxis is used to postpone CMV infection or reactivation to a
later point in the post-transplantation.
CMV infection/reactivation does not always lead to clinical disease. Valganciclovir (oral)
can be used when CMV DNA is detected in the blood, but patient has no or few complaints.
However, in case of severe symptoms such as colitis, nephritis, hepatitis, pneumonitis,
uveitis or encephalitis (active CMV disease) then ganciclovir is indicated intravenously. In
clinical recovery treatment is often completed with valganciclovir.
It is important that the ganciclovir level is adequate, because too high level can lead to
side effects such as cytopenia and a too low level can lead to treatment failure and
resistance development. There are different dosing schedules mentioned in different sources.
These schemes are based on dated literature.
The aim of (val)ganciclovir therapeutic drug monitoring (TDM) is to gain more insight into
the pharmacodynamics and pharmacokinetics of ganciclovir, in the context of prophylaxis and
treatment of CMV infections, in order to provide the patient with an adequate dose.
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