Assessing the Risk of CMV Infection of the Renal Transplant About R + by Cellular Immunity Analyzed by the QuantiFERON ®-CMV Test. (QUANTIC-R+)
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|ClinicalTrials.gov Identifier: NCT02064699|
Recruitment Status : Terminated
First Posted : February 17, 2014
Last Update Posted : March 29, 2018
Cytomegalovirus (CMV) infection was observed in over 30% of organ recipients with high morbidity. Moreover, no prophylaxis, 75% R + D-transplanted, 55%, R + D + and D-25% R + develop CMV. The number of available antiviral drugs is reduced and noticeable side effects (neutropenia, renal toxicity) lead to premature discontinuation of therapy or the use of reduced doses that promote non-response to treatment and the emergence of resistance. In case of neutropenia, there are more an increased risk of secondary rejection due to the reduction of immunosuppressive treatment rendered necessary by the haematological reached.
Rational use of these molecules is necessary with essential today as the optimal duration of prophylaxis primary issues and the prophylaxis of recurrences in case of CMV infection reported in.
|Condition or disease||Intervention/treatment|
|Renal Transplant Recipient Immunized Against the Cytomegalovirus||Biological: CMV Infection|
|Study Type :||Observational|
|Actual Enrollment :||75 participants|
|Official Title:||Assessing the Risk of CMV Infection of the Renal Transplant About R + by Cellular Immunity Analyzed by the QuantiFERON ®-CMV Test.|
|Actual Study Start Date :||May 2013|
|Actual Primary Completion Date :||December 13, 2017|
|Actual Study Completion Date :||December 13, 2017|
Renal transplant recipient immunized against the Cytomegalovirus
Biological: CMV Infection
Routine follow-up (viral load, creatininaemia, neutrophil count, isolation of CMV strains when possible) and biological sample collection for.
Using the QuantiFERON-CMV test for predicting the risk of CMV infection in the transplanted immune against CMV.
- Predictive values of Cytomegalovirus infection [ Time Frame: 1 week ]CMV infection defined by a positive ADNémie confirmed on a second sample ideally one week apart.
- No response to treatment [ Time Frame: 21 days ]Persistence of an active CMV infection defined by a persistent ADNémie for more than 21 days under antiviral treatment.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064699
|Besancon, France, 25|
|Caen, France, 14|
|Clermont Ferrand, France, 63|
|Grenoble, France, 38|
|Lille, France, 59|
|Limoges, France, 87042|
|Nantes, France, 44|
|Reims, France, 51|
|Rennes, France, 35|
|Saint-etienne, France, 42|
|Strasbourg, France, 67|
|Suresnes, France, 92151|
|Principal Investigator:||Sophie ALAIN, MD||Limoges UH|