Observational Study Comparing the Efficacy of Ganciclovir as a Function of Blood Exposure to the Drug During a Curative or Preemptive Treatment
- Conditions
- Solid Organ Transplantation
- Registration Number
- NCT03088553
- Lead Sponsor
- Rennes University Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 138
- 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.
- pregnancy
- opposition to participate in the study
- incapable person
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Centre Hospitalier Universitaire de Rennes
🇫🇷Rennes, France