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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Brief Summary:

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

Detailed Description:
QuantiFERON-CMV ® is a fast and standardized test that evaluates the CMV specific cellular immunity measuring the amount of secreted Interferon gamma (IFN gamma) in plasma by ELISA. It uses more epitopes of proteins including CMV glycoprotein B (gB), protein IE-1 and protein pp65 and protein pp50, which are specific for (human leukocyte antigen) HLA class I. Pretreatment of the sample is simple and plasma can be stored, frozen, for a delayed dose of interferon.

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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
CMV infection
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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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
Detection of the CMV in sang, the leukocytes, or plasma with or without the viral quantification.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Renal transplant recipient Immunized against the Cytomegalovirus.
Criteria

Inclusion Criteria:

  • Renal transplant recipient
  • Immunized against the Cytomegalovirus

Exclusion Criteria:

  • Not willing to participate, no health insurance
  • clinical evidence of active viral infection
  • renal transplant recipient whose treatment includes induction antilymphocyte antibodies

Information from the National Library of Medicine

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


Locations
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France
Virologie
Besancon, France, 25
Virologie
Caen, France, 14
Virologie
Clermont Ferrand, France, 63
Virologie
Grenoble, France, 38
Virologie
Lille, France, 59
Bactériologie Virologie
Limoges, France, 87042
Virologie
Nantes, France, 44
Virologie
Reims, France, 51
Virologie
Rennes, France, 35
Virologie
Saint-etienne, France, 42
Virologie
Strasbourg, France, 67
Foch Hospital
Suresnes, France, 92151
Sponsors and Collaborators
University Hospital, Limoges
Investigators
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Principal Investigator: Sophie ALAIN, MD Limoges UH

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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT02064699     History of Changes
Other Study ID Numbers: I10002 QUANTIC-R+
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Keywords provided by University Hospital, Limoges:
Renal transplant
CMV
Test QuantiFERON-CMV

Additional relevant MeSH terms:
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Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases