NCT02064699

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2017

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

4.6 years

First QC Date

February 14, 2014

Last Update Submit

July 29, 2025

Conditions

Renal Transplant RecipientImmunized Against the Cytomegalovirus

Keywords

Renal transplantCMVTest QuantiFERON-CMV

Outcome Measures

Primary Outcomes (1)

  • Predictive values of Cytomegalovirus infection

    CMV infection defined by a positive ADNémie confirmed on a second sample ideally one week apart.

    1 week

Secondary Outcomes (1)

  • No response to treatment

    21 days

Study Arms (1)

CMV infection

Renal transplant recipient immunized against the Cytomegalovirus

Biological: CMV Infection

Interventions

CMV InfectionBIOLOGICAL

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.

CMV infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Renal transplant recipient Immunized against the Cytomegalovirus.

You may qualify if:

  • Renal transplant recipient
  • Immunized against the Cytomegalovirus

You may not qualify if:

  • Not willing to participate, no health insurance
  • clinical evidence of active viral infection
  • renal transplant recipient whose treatment includes induction antilymphocyte antibodies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Virologie

Besançon, 25, France

Location

Virologie

Caen, 14, France

Location

Virologie

Clermont-Ferrand, 63, France

Location

Virologie

Grenoble, 38, France

Location

Virologie

Lille, 59, France

Location

Bactériologie Virologie

Limoges, 87042, France

Location

Virologie

Nantes, 44, France

Location

Virologie

Reims, 51, France

Location

Virologie

Rennes, 35, France

Location

Virologie

Saint-Etienne, 42, France

Location

Virologie

Strasbourg, 67, France

Location

Foch Hospital

Suresnes, 92151, France

Location

Related Publications (2)

  • Rutkow IM. Crawford Williamson Long. Arch Surg. 1999 May;134(5):578. doi: 10.1001/archsurg.134.5.578. No abstract available.

    PMID: 10323437BACKGROUND

  • Mafi S, Essig M, Rerolle JP, Lagathu G, Crochette R, Brodard V, Schvartz B, Gouarin S, Bouvier N, Engelmann I, Garstka A, Bressollette-Bodin C, Cantarovitch D, Germi R, Janbon B, Archimbaut C, Heng AE, Garnier F, Gomes-Mayeras M, Labrunie A, Hantz S, Alain S. Torque teno virus viremia and QuantiFERON(R)-CMV assay in prediction of cytomegalovirus reactivation in R+ kidney transplant recipients. Front Med (Lausanne). 2023 Jun 22;10:1180769. doi: 10.3389/fmed.2023.1180769. eCollection 2023.

    PMID: 37425298DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Detection of the CMV in sang, the leukocytes, or plasma with or without the viral quantification.

Study Officials

  • Sophie ALAIN, MD

    Limoges UH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2014

First Posted

February 17, 2014

Study Start

May 1, 2013

Primary Completion

December 13, 2017

Study Completion

December 13, 2017

Last Updated

August 1, 2025

Record last verified: 2025-07

Locations

FR(12)