(Val)Ganciclovir TDM in Transplant Recipients

University Medical Center Groningen (UMCG)

Status: Unknown

Conditions: Cytomegalovirus Infections

Treatments: Drug: Ganciclovir; Drug: Valganciclovir

Study type: Observational

Funder types: Other

Identifiers

NCT03698435

201800021

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must receive ganciclovir intravenously or valganciclovir orally as routine care
• Must have received a solid organ or stem cell transplant
• Must be be 18 years or older

Exclusion criteria

There are no exclusion criteria.

Trial design

100 participants in 2 patient groups

Prophylaxis

Description:

Patients who receive (val)ganciclovir for prophylaxis of cytomegalovirus

Treatment:

Drug: Valganciclovir

Drug: Ganciclovir

Treatment

Description:

Patients who receive (val)ganciclovir for treatment of cytomegalovirus

Treatment:

Drug: Valganciclovir

Drug: Ganciclovir