NCT02538172

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

Completed NA Last updated 27 April 2021

What this trial tests

NA trial testing T-Track® CMV assay in Cytomegalovirus Infections in 195 participants. Completed in 1 January 2021.

Timeline

1 October 2015

Primary endpoint
1 December 2019

1 January 2021

Quick facts

Lead sponsor	University of Lausanne Hospitals
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	195
Start date	1 October 2015
Primary completion	1 December 2019
Estimated completion	1 January 2021
Sites	5 locations across Switzerland

Drugs / interventions tested

• T-Track® CMV assay

Conditions studied

• Cytomegalovirus Infections — all drugs for Cytomegalovirus Infections →

Sponsor

University of Lausanne Hospitals

Who can join

18 and older, any sex, with Cytomegalovirus Infections. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Incidence of CMV infection
  Time frame: one year
• Duration of antiviral prophylaxis
  Time frame: one year

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Progress and Challenges in the Prevention, Diagnosis, and Management of Cytomegalovirus Infection in Transplantation.
   Limaye AP, Babu TM, Boeckh M. · · 2020 · cited 87× · PMID 33115722 · DOI 10.1128/cmr.00043-19
2. Standardized monitoring of cytomegalovirus-specific immunity can improve risk stratification of recurrent cytomegalovirus reactivation after hematopoietic stem cell transplantation.
   Wagner-Drouet E, Teschner D, Wolschke C, Janson D, et al · · 2021 · cited 34× · PMID 31879324 · DOI 10.3324/haematol.2019.229252
3. Immune Monitoring-Guided Versus Fixed Duration of Antiviral Prophylaxis Against Cytomegalovirus in Solid-Organ Transplant Recipients: A Multicenter, Randomized Clinical Trial.
   Manuel O, Laager M, Hirzel C, Neofytos D, et al · · 2024 · cited 31× · PMID 37738676 · DOI 10.1093/cid/ciad575
4. CMV Prevention and Treatment in Transplantation: What's New in 2019.
   Stern A, Papanicolaou GA. · · 2019 · cited 23× · PMID 31732823 · DOI 10.1007/s11908-019-0699-0
5. Use of T Cell Mediated Immune Functional Assays for Adjustment of Immunosuppressive or Anti-infective Agents in Solid Organ Transplant Recipients: A Systematic Review.
   Rezahosseini O, Møller DL, Knudsen AD, Sørensen SS, et al · · 2020 · cited 17× · PMID 33178194 · DOI 10.3389/fimmu.2020.567715
6. Immunological Prediction of Cytomegalovirus (CMV) Replication Risk in Solid Organ Transplantation Recipients: Approaches for Regulating the Targeted Anti-CMV Prevention Strategies.
   Han SH. · · 2017 · cited 14× · PMID 29027383 · DOI 10.3947/ic.2017.49.3.161
7. Laboratory diagnostic testing for cytomegalovirus infection in solid organ transplant patients.
   Lee H, Oh EJ. · · 2022 · cited 11× · PMID 35769434 · DOI 10.4285/kjt.22.0001
8. Transplant Trial Watch.
   O'Callaghan JM, Knight SR. · · 2024 · PMID 38317691 · DOI 10.3389/ti.2024.12597