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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-21

Study Completion Date

2024-06-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Solid Organ Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Therapeutic Drug Monitoring

Trough concentration of ganciclovir and viral load measurement at each follow-up visit.

Intervention Type DRUG

Eligibility Criteria

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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.