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

University Health Network, Toronto

Status: Completed

Conditions: Cytomegalovirus Viraemia

Treatments: Device: Quantiferon-CMV assay

Study type: Interventional

Funder types: Other

Identifiers

NCT02784756

15-9877

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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134 participants in 1 patient group

Quantiferon-CMV assay

Other group

Description:

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

Treatment:

Device: Quantiferon-CMV assay