QUANTIC-R+: Assessing the Risk of CMV Infection of the Renal Transplant About R + by Cellular Immunity Analyzed by the QuantiFERON ®-CMV Test.
Study Details
Study Description
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 | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Predictive values of Cytomegalovirus infection [1 week]
CMV infection defined by a positive ADNémie confirmed on a second sample ideally one week apart.
Secondary Outcome Measures
- No response to treatment [21 days]
Persistence of an active CMV infection defined by a persistent ADNémie for more than 21 days under antiviral treatment.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Virologie | Besancon | France | 25 | |
| 2 | Virologie | Caen | France | 14 | |
| 3 | Virologie | Clermont Ferrand | France | 63 | |
| 4 | Virologie | Grenoble | France | 38 | |
| 5 | Virologie | Lille | France | 59 | |
| 6 | Bactériologie Virologie | Limoges | France | 87042 | |
| 7 | Virologie | Nantes | France | 44 | |
| 8 | Virologie | Reims | France | 51 | |
| 9 | Virologie | Rennes | France | 35 | |
| 10 | Virologie | Saint-etienne | France | 42 | |
| 11 | Virologie | Strasbourg | France | 67 | |
| 12 | Foch Hospital | Suresnes | France | 92151 |
Sponsors and Collaborators
- University Hospital, Limoges
Investigators
- Principal Investigator: Sophie ALAIN, MD, Limoges UH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- I10002 QUANTIC-R+