Cell-mediated Immunity for Prevention of CMV Disease

April 27, 2021 updated by: Oriol Manuel, University of Lausanne Hospitals

Monitoring of Specific Cytomegalovirus Cell-mediated Immunity (CMV-CMI) for Optimization of Preventive Strategies Against CMV Infection in High-risk Solid-organ Transplant Recipients

An open-label randomized controlled trial to adapt the duration of antiviral prophylaxis in D+/R- patients and in R+ patients receiving ATG according to the result of the T-Track® CMV assay. Investigators will include kidney and liver transplant recipients. Patients will be randomized during the first month post transplant.

In the interventional arm, while the patient is on antiviral prophylaxis, CMI will be monitored every 4 weeks from the 2nd month after transplant. Measurement of CMV CMI will be done in real time by using the T-Track® CMV assay. The continuation of antiviral prophylaxis will depend on the result of the assay:

  • T-Track positive (patient at lower risk): discontinuation of the antiviral drug
  • T-Track negative (patient at higher risk): continuation of the antiviral drug until the maximal duration of prophylaxis (3 to 6 months) The standard arm will receive a standard fixed duration of antiviral prophylaxis (3 months for R+ thymoglobulin treated-patients and 6 months for D+/R- patients). Measurement of CMV CMI by both T-Track® CMV and the Quantiferon-CMV® assays will be done at the same time points of the interventional arm, but the result will not be known by the investigators.

After discontinuation of prophylaxis, patients in both arms will be followed for the development of CMV replication at each visit using the local PCR assay and antiviral therapy will be administered in case of CMV infection according to local guidelines.

The co-primary endpoints will be the incidence of CMV disease or antiviral-treated CMV replication during the first 12 months post transplant AND the duration of antiviral prophylaxis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Not Applicable

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

  • Switzerland
      • Basel, Switzerland, 4051
        • Universität Basel
      • Bern, Switzerland, 3010
        • Universitätsspital Bern
      • Genève, Switzerland, 1205
        • Hopitaux Universitaires de Geneve
      • St. Gallen, Switzerland, 9007
        • Kantonsspital St.Gallen
      • Zürich, Switzerland, 8091
        • Universitätsspital Zürich

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years old
  • Kidney or liver transplantation
  • Scheduled to receive CMV antiviral prophylaxis:
  • CMV D+/R- patients
  • Patients receiving lymphocyte-depleting antibodies (thymoglobulin® or ATG®)

Exclusion Criteria:

  • Unable to provide informed consent
  • Unable or unwilling to comply with study protocol

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

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
T-Track® CMV assay Quantiferon-CMV® assays Valganciclovir
Other: T-Track® CMV assay
Other Names:
  • Valganciclovir
  • Quantiferon-CMV® assays
Other: Control
T-Track® CMV assay Quantiferon-CMV® assays Valganciclovir
Other: T-Track® CMV assay
Other Names:
  • Valganciclovir
  • Quantiferon-CMV® assays

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of CMV infection
Time Frame: one year
one year
Duration of antiviral prophylaxis
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Graft survival
Time Frame: one year
one year
Incidence of CMV viremia using standardized measure
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

University of Lausanne Hospitals

Investigators

  • Principal Investigator: Oriol Manuel, MD, University of Lausanne Hospitals

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

October 1, 2015

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

August 26, 2015

First Submitted That Met QC Criteria

August 28, 2015

First Posted (Estimate)

September 2, 2015

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STCS FUP # 052

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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