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| Name | Class |
|---|---|
| Canadian National Transplant Research Program | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quantiferon-CMV assay | Other | All patients will receive a CMV-immunity test at specific time points during the study. This is a single arm design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantiferon-CMV assay | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic CMV disease | Number of participants with symptomatic CMV disease (including viral syndrome and tissue invasive disease) at 1 year post-transplant. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of CMV viremia | Occurrence of CMV viremia as measured by QuantiFERON-CMV assay (> 1000 IU/mL) | 1 year |
| positive vs. negative cell-mediated immunity assays | Incidence of positive vs. negative cell-mediated immunity assays post-transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Atul Humar, MD | University Health Network, Toronto | Principal Investigator |
| Deepali Kumar, MD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | T6G 2G3 | Canada | ||
| St. Paul's Hospital - Providence Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32504089 | Derived | Gibson L. An Interferon-gamma Release Assay for Evaluation of Cell-mediated Immunity in Infants With Congenital Cytomegalovirus Infection. Clin Infect Dis. 2021 Aug 2;73(3):374-375. doi: 10.1093/cid/ciaa700. No abstract available. |
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| 1 year |
| Vancouver |
| British Columbia |
| V6Z 1Y6 |
| Canada |
| London Health Sciences Centre | London | Ontario | N6A 4V2 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5C 2T2 | Canada |
| University Health Network, Toronto General Hospital | Toronto | Ontario | M5G 2N2 | Canada |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |