Clinical trial NCT02064699: Assessing the Risk of CMV Infection of the Renal Transplant About R + by Cellular Immunity Analyzed by the QuantiFERON ®-CMV Test.
Official title: Assessing the Risk of CMV Infection of the Renal Transplant About R + by Cellular Immunity Analyzed by the QuantiFERON ®-CMV Test.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Renal Transplant Recipient
Immunized Against the Cytomegalovirus
Keywords: Renal transplant
CMV
Test QuantiFERON-CMV
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2014-02-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Renal transplant recipient Immunized against the Cytomegalovirus.

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.

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.

Eligibility 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

Primary outcomes:
measure: Predictive values of Cytomegalovirus infection
timeFrame: 1 week
Secondary outcomes:
measure: No response to treatment
timeFrame: 21 days
Other outcomes:
Locations:
city: Besancon
country: France
facility: Virologie
city: Caen
country: France
facility: Virologie
city: Clermont Ferrand
country: France
facility: Virologie
city: Grenoble
country: France
facility: Virologie
city: Lille
country: France
facility: Virologie
city: Limoges
country: France
facility: Bactériologie Virologie
city: Nantes
country: France
facility: Virologie
city: Reims
country: France
facility: Virologie
city: Rennes
country: France
facility: Virologie
city: Saint-etienne
country: France
facility: Virologie
city: Strasbourg
country: France
facility: Virologie
city: Suresnes
country: France
facility: Foch Hospital
Study officials:
affiliation: Limoges UH
name: Sophie ALAIN, MD
role: PRINCIPAL_INVESTIGATOR
References: