Observational Study Comparing the Efficacy of Ganciclovir as a Function of Blood Exposure to the Drug During a Curative or Preemptive Treatment

Last updated: April 11, 2023
Sponsor: Rennes University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03088553
35RC16_9773
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • pregnancy
  • opposition to participate in the study
  • incapable person

Study Design

Total Participants: 138
Study Start date:
February 21, 2017
Estimated Completion Date:
June 21, 2024

Study 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.

Connect with a study center

  • Centre Hospitalier Universitaire de Rennes

    Rennes, 35000
    France

    Active - Recruiting

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