search
Back to results

Cell-mediated Immunity for Prevention of CMV Disease

Primary Purpose

Cytomegalovirus Infections

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
T-Track® CMV assay
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cytomegalovirus Infections focused on measuring Cell-mediated immunity, Antiviral prophylaxis, Transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universität Basel
  • Universitätsspital Bern
  • Hopitaux Universitaires de Genève
  • Kantonsspital St.Gallen
  • UniversitätsSpital Zürich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Control

Arm Description

T-Track® CMV assay Quantiferon-CMV® assays Valganciclovir

T-Track® CMV assay Quantiferon-CMV® assays Valganciclovir

Outcomes

Primary Outcome Measures

Incidence of CMV infection
Duration of antiviral prophylaxis

Secondary Outcome Measures

Graft survival
Incidence of CMV viremia using standardized measure

Full Information

First Posted
August 26, 2015
Last Updated
April 27, 2021
Sponsor
University of Lausanne Hospitals
search

1. Study Identification

Unique Protocol Identification Number
NCT02538172
Brief Title
Cell-mediated Immunity for Prevention of CMV Disease
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 Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
January 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infections
Keywords
Cell-mediated immunity, Antiviral prophylaxis, Transplantation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
T-Track® CMV assay Quantiferon-CMV® assays Valganciclovir
Arm Title
Control
Arm Type
Other
Arm Description
T-Track® CMV assay Quantiferon-CMV® assays Valganciclovir
Intervention Type
Other
Intervention Name(s)
T-Track® CMV assay
Other Intervention Name(s)
Quantiferon-CMV® assays, Valganciclovir
Primary Outcome Measure Information:
Title
Incidence of CMV infection
Time Frame
one year
Title
Duration of antiviral prophylaxis
Time Frame
one year
Secondary Outcome Measure Information:
Title
Graft survival
Time Frame
one year
Title
Incidence of CMV viremia using standardized measure
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oriol Manuel, MD
Organizational Affiliation
University of Lausanne Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universität Basel
City
Basel
ZIP/Postal Code
4051
Country
Switzerland
Facility Name
Universitätsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Hopitaux Universitaires de Genève
City
Genève
ZIP/Postal Code
1205
Country
Switzerland
Facility Name
Kantonsspital St.Gallen
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
UniversitätsSpital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23196955
Citation
Manuel O, Husain S, Kumar D, Zayas C, Mawhorter S, Levi ME, Kalpoe J, Lisboa L, Ely L, Kaul DR, Schwartz BS, Morris MI, Ison MG, Yen-Lieberman B, Sebastian A, Assi M, Humar A. Assessment of cytomegalovirus-specific cell-mediated immunity for the prediction of cytomegalovirus disease in high-risk solid-organ transplant recipients: a multicenter cohort study. Clin Infect Dis. 2013 Mar;56(6):817-24. doi: 10.1093/cid/cis993. Epub 2012 Nov 29.
Results Reference
result
PubMed Identifier
24078428
Citation
Manuel O. Clinical Experience with Immune Monitoring for Cytomegalovirus in Solid-Organ Transplant Recipients. Curr Infect Dis Rep. 2013 Sep 29. doi: 10.1007/s11908-013-0369-6. Online ahead of print.
Results Reference
result
PubMed Identifier
20353469
Citation
Humar A, Lebranchu Y, Vincenti F, Blumberg EA, Punch JD, Limaye AP, Abramowicz D, Jardine AG, Voulgari AT, Ives J, Hauser IA, Peeters P. The efficacy and safety of 200 days valganciclovir cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Am J Transplant. 2010 May;10(5):1228-37. doi: 10.1111/j.1600-6143.2010.03074.x. Epub 2010 Mar 26.
Results Reference
result

Learn more about this trial

Cell-mediated Immunity for Prevention of CMV Disease

We'll reach out to this number within 24 hrs