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

Renal Transplant Recipient Clinical Trial

— QUANTIC-R+  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02064699
• Other study ID #: I10002 QUANTIC-R+
• Status: Terminated
• Start date: May 2013
• Est. completion date: December 13, 2017

Study information

• Verified date: October 2019
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: December 13, 2017
• Est. primary completion date: December 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cytomegalovirus Infections
• Immunized Against the Cytomegalovirus
• Renal Transplant Recipient

Intervention

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.

Locations

Country	Name	City	State
France	Virologie	Besancon
France	Virologie	Caen
France	Virologie	Clermont Ferrand
France	Virologie	Grenoble
France	Virologie	Lille
France	Bactériologie Virologie	Limoges
France	Virologie	Nantes
France	Virologie	Reims
France	Virologie	Rennes
France	Virologie	Saint-etienne
France	Virologie	Strasbourg
France	Foch Hospital	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive values of Cytomegalovirus infection	CMV infection defined by a positive ADNémie confirmed on a second sample ideally one week apart.	1 week
Secondary	No response to treatment	Persistence of an active CMV infection defined by a persistent ADNémie for more than 21 days under antiviral treatment.	21 days