Solid Organ Transplantation
Conditions
Keywords
Ganciclovir, trough concentrations, CMV viral load, safety, Solid organ transplantation (heart, kidney or liver)
Brief summary
This study aims to better define the target range of ganciclovir trough concentrations by investigating the relationship between ganciclovir concentration and the time to undetectable CMV-DNA load, in preemptive and curative treatments by (val)ganciclovir.
Detailed description
The primary objective of the study is to determine whether higher concentrations of ganciclovir can reduce the time of negation of the CMV-DNA load. Secondary objectives are to determine the concentration-toxicity relationship of ganciclovir and the relationship between concentrations of ganciclovir and apparition of CMV gene mutations responsible of drug resistance. Each week, trough concentrations of ganciclovir are measured, associated with control of CMV-DNA load and all biological analysis currently necessary for the monitoring of the infection.
Interventions
DRUGTherapeutic Drug Monitoring
Trough concentration of ganciclovir and viral load measurement at each follow-up visit.
Sponsors
Rennes University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* more than 18 years-old * Solid organ transplanted patients needing a treatment by oral or intravenous (val)ganciclovir * Non-opposition to participate in the study.
Exclusion criteria
* pregnancy * opposition to participate in the study * incapable person
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to CMV viral load negativity as a function of the median of trough concentrations of ganciclovir | through study completion, an average of 1 year | Duration of patient follow-up for the CMV infection |
Countries
France
Contacts
Primary ContactKristell COAT
Backup ContactDirection de la recherche
Outcome results
None listed