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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
134
University of Alberta Hospital
Edmonton, Alberta, Canada
St. Paul's Hospital - Providence Health
Vancouver, British Columbia, Canada
London Health Sciences Centre
London, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Symptomatic CMV disease
Number of participants with symptomatic CMV disease (including viral syndrome and tissue invasive disease) at 1 year post-transplant.
Time frame: 1 year
Occurrence of CMV viremia
Occurrence of CMV viremia as measured by QuantiFERON-CMV assay (\> 1000 IU/mL)
Time frame: 1 year
positive vs. negative cell-mediated immunity assays
Incidence of positive vs. negative cell-mediated immunity assays post-transplant
Time frame: 1 year
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University Health Network, Toronto General Hospital
Toronto, Ontario, Canada
Hospital Universitario 12 de Octubre
Madrid, Spain