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Cell-mediated Immunity for Prevention of CMV Disease

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ClinicalTrials.gov Identifier: NCT02538172
Recruitment Status : Recruiting
First Posted : September 2, 2015
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Oriol Manuel, University of Lausanne Hospitals

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cytomegalovirus Infections Other: T-Track® CMV assay Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Monitoring of Specific Cytomegalovirus Cell-mediated Immunity (CMV-CMI) for Optimization of Preventive Strategies Against CMV Infection in High-risk Solid-organ Transplant Recipients
Study Start Date : October 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
T-Track® CMV assay Quantiferon-CMV® assays Valganciclovir
Other: T-Track® CMV assay
Other Names:
  • Quantiferon-CMV® assays
  • Valganciclovir

Control
T-Track® CMV assay Quantiferon-CMV® assays Valganciclovir
Other: T-Track® CMV assay
Other Names:
  • Quantiferon-CMV® assays
  • Valganciclovir




Primary Outcome Measures :
  1. Incidence of CMV infection [ Time Frame: one year ]
  2. Duration of antiviral prophylaxis [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Graft survival [ Time Frame: one year ]
  2. Incidence of CMV viremia using standardized measure [ Time Frame: one year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538172


Contacts
Contact: Oriol Manuel, MD +41 21 314 30 20 oriol.manuel@chuv.ch
Contact: Deolinda Alves +41 21 314 10 01 deolinda.alves@chuv.ch

Locations
Switzerland
Universität Basel Recruiting
Basel, Switzerland, 4051
Contact: Hans Hirsch, MD       hans.hirsch@unibas.ch   
Principal Investigator: Hans Hirsch, MD         
Universitätsspital Bern Recruiting
Bern, Switzerland, 3010
Contact: Cedric HIrzel, MD       Cedric.Hirzel@insel.ch   
Principal Investigator: Cedric Hirzel, MD         
Hopitaux Universitaires de Genève Recruiting
Genève, Switzerland, 1205
Contact: Christian Van Delden, MD       Christian.vanDelden@hcuge.ch   
Principal Investigator: Christian Van Delden, MD         
Kantonsspital St.Gallen Recruiting
St. Gallen, Switzerland, 9007
Contact: Matthias Hoffmann, MD       Matthias.Hoffmann@kssg.ch   
Principal Investigator: Matthias Hoffmann, MD         
UniversitätsSpital Zürich Recruiting
Zürich, Switzerland, 8091
Contact: Nicolas Mueller, MD       Nicolas.Mueller@usz.ch   
Principal Investigator: Nicolas Mueller, MD         
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Principal Investigator: Oriol Manuel, MD University of Lausanne Hospitals

Publications of Results:
Responsible Party: Oriol Manuel, Privat-Docent (PD), University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT02538172     History of Changes
Other Study ID Numbers: STCS FUP # 052
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

Keywords provided by Oriol Manuel, University of Lausanne Hospitals:
Cell-mediated immunity
Antiviral prophylaxis
Transplantation

Additional relevant MeSH terms:
Infection
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valganciclovir
Antiviral Agents
Anti-Infective Agents