Assessing the Risk of CMV Infection of the Renal Transplant About R + by Cellular Immunity Analyzed by the QuantiFERON ®-CMV Test.

Terminated

• Conditions: Renal Transplant Recipient; Immunized Against the Cytomegalovirus
• Interventions: Biological: CMV Infection

• Registration Number: NCT02064699
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-05
• Study First Submitted: 2014-02-14
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-17
• Primary Completion: 2017-12-13
• Study Completion: 2017-12-13
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-23
• Last Update Posted: 2019-10-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CMV infection	CMV Infection	Renal transplant recipient immunized against the Cytomegalovirus

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (3)

Virologie; 🇫🇷 Strasbourg, France

Bactériologie Virologie; 🇫🇷 Limoges, France

Foch Hospital; 🇫🇷 Suresnes, France