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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic Drug Monitoring | Drug | Trough concentration of ganciclovir and viral load measurement at each follow-up visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to CMV viral load negativity as a function of the median of trough concentrations of ganciclovir | Duration of patient follow-up for the CMV infection | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Solid organ transplanted patients with CMV reactivation or CMV disease.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristell COAT | Contact | 2 99 28 91 91 | +33 | kristell.coat@chu-rennes.fr |
| Direction de la recherche | Contact | 2 99 28 25 55 | +33 | DRC@chu-rennes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Rennes | Recruiting | Rennes | 35000 | France |
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| ID | Term |
|---|---|
| D054069 | Multiple Acyl Coenzyme A Dehydrogenase Deficiency |
| ID | Term |
|---|---|
| D000592 | Amino Acid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D028361 | Mitochondrial Diseases |
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