Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2020-04-30

Brief Summary

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The study will prospectively determine the clinical utility of CMV cell-mediated immunity using the Quantiferon test. The investigators will use the assay results to tailor the duration of CMV prophylaxis in solid organ transplant patients.

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Detailed Description

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Cytomegalovirus (CMV) disease is an important cause of morbidity in solid organ transplantation recipients and remains the most common opportunistic viral infection in these patients. Standard CMV prevention strategies include universal prophylaxis and pre-emptive therapy with viral load monitoring. However, neither of these strategies has been successful in eliminating CMV disease as seen by high rates of viremia, incidence, and CMV recurrence despite treatment. Recently, the Quantiferon-CMV assay has been shown to predict late CMV reactivation after prophylaxis and to be predictive of viral progression and the need for antiviral therapy in organ transplant recipients who develop low level CMV viremia. The purpose of the current study is to test the clinical strategy of using the Quantiferon-CMV assay in guiding the duration of primary CMV prophylaxis in solid organ transplant patients.

Conditions

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Cytomegalovirus Viraemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Quantiferon-CMV assay

All patients will receive a CMV-immunity test at specific time points during the study. This is a single arm design

Group Type OTHER

Quantiferon-CMV assay

Intervention Type DEVICE

Interventions

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Quantiferon-CMV assay

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult kidney, kidney-pancreas, liver transplant recipient, or heart transplant recipient
* CMV D+/R- patient or any R+ patient who received antithymocyte globulin induction therapy

Exclusion Criteria

* Unable to comply with protocol
* Campath (Alemtuzumab) induction
* Receiving another investigational compound for CMV treatment or prophylaxis.
* Allergy to valganciclovir or ganciclovir
* Receiving an investigational compound for prevention or treatment of rejection, or participating in another interventional study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No