Cell-mediated Immunity for Prevention of CMV Disease

Not Applicable

Completed

• Conditions: Cytomegalovirus Infections
• Interventions: Other: T-Track® CMV assay

• Registration Number: NCT02538172
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-26
• Study First Submitted QC: 2015-08-28
• Study First Posted: 2015-09-02
• Study Start: 2015-10
• Primary Completion: 2019-12
• Study Completion: 2021-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	T-Track® CMV assay	T-Track® CMV assay Quantiferon-CMV® assays Valganciclovir
Intervention	T-Track® CMV assay	T-Track® CMV assay Quantiferon-CMV® assays Valganciclovir

Primary Outcome Measures

Name	Time	Method
Incidence of CMV infection	one year
Duration of antiviral prophylaxis	one year

Secondary Outcome Measures

Name	Time	Method
Graft survival	one year
Incidence of CMV viremia using standardized measure	one year

Trial Locations

Locations (5)

Universität Basel; 🇨🇭 Basel, Switzerland

Universitätsspital Bern; 🇨🇭 Bern, Switzerland

Kantonsspital St.Gallen; 🇨🇭 St. Gallen, Switzerland

Hopitaux Universitaires de Genève; 🇨🇭 Genève, Switzerland

UniversitätsSpital Zürich; 🇨🇭 Zürich, Switzerland