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

July 29, 2025 updated by: University Hospital, Limoges

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25
        • Virologie
      • Caen, France, 14
        • Virologie
      • Clermont Ferrand, France, 63
        • Virologie
      • Grenoble, France, 38
        • Virologie
      • Lille, France, 59
        • Virologie
      • Limoges, France, 87042
        • Bactériologie Virologie
      • Nantes, France, 44
        • Virologie
      • Reims, France, 51
        • Virologie
      • Rennes, France, 35
        • Virologie
      • Saint-etienne, France, 42
        • Virologie
      • Strasbourg, France, 67
        • Virologie
      • Suresnes, France, 92151
        • Foch Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Renal transplant recipient Immunized against the Cytomegalovirus.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Investigators

  • Principal Investigator: Sophie ALAIN, MD, Limoges UH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

December 13, 2017

Study Completion (Actual)

December 13, 2017

Study Registration Dates

First Submitted

February 14, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (Estimated)

February 17, 2014

Study Record Updates

Last Update Posted (Actual)

August 1, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I10002 QUANTIC-R+

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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