Table 2.
Summary of the registered interventional study protocols.
| Code, location Start year [Reference no.] | Number of patients vs. controls | Detection method [Reference no.] | Study design | Summary of methods | Aims of the study |
|---|---|---|---|---|---|
| NCT01424345, USA, 2011, NIH (45), (This trial finished in 2012, but the results are not accessible). | Adult kidney transplant recipients (Estimated number of participants is 40) | ImmuKnow® | Randomized controlled trial | Adult kidney transplant recipients will be included in this study. The dosage of immunosuppressive agents in the control group will be adjusted according to the current laboratory results. In the intervention group, the dosage of immunosuppressive agents will be adjusted according to the results of ImmuKnow and the routine post-transplant lab results. Both of the groups will be followed up for 12 months after transplantation. | To define the proportion of infection and rejection during the first year after transplantation. To define the quality of life of the kidney transplant recipients one-year post-transplantation. To define allograft function and graft and recipient survival in the first year post-transplantation. |
| NCT03699254, Spain, 2011, Paez-Vega et al. (46) | Adult lung transplant recipients (Estimated number of participants is 150 including 75 in the interventional and 75 in the control group) | QuantiFERON®-CMV assay | Phase III randomized, multicenter, non-inferiority clinical trial | Adult lung transplant recipients who are at risk of CMV reactivation (–/R+) will include in this study. In the control group, lung transplant recipients will receive anti-CMV prophylaxis for 6 months post-transplantation. From the end of the sixth month up to the end of the twelfth month, episodes of CMV reactivation will be treated by antivirals. In the intervention group, lung transplant recipients will receive antiviral prophylaxis for 3 months after transplantation. QuantiFERON®-CMV will be done at the end of the third month, and antiviral prophylaxis will be discontinued if the QuantiFERON®-CMV is positive (≥0.2 IU/mL IFN-γ). If the QuantiFERON®-CMV is negative, antivirals prophylaxis will be continued for one additional month, and this process will be repeated monthly up to the end of the twelfth month after transplantation. All the recipients will follow for 18 months or more post-transplantation for any evidence of CMV infection. |
To define the efficacy of the immune-guided antiviral prophylaxis for the prevention of CMV disease in lung transplant recipients (Intervention group). To define the efficacy of the universal antiviral prophylaxis for the prevention of CMV disease in lung transplant recipients (Control group). To compare interventional and control groups. To define a new cut-off for the QuantiFERON®-CMV assay, if applicable. |
| CN-01898092, Czech Republic, 2018, ILTS (47) | Adult kidney transplant recipients (Estimated number of participants is 150) | Quantiferon®-CMV assay | Phase IV randomized, non-inferiority clinical trial | Prior to transplantation adult kidney transplant recipients who are D+/R–, D+/R+, or D-/R+ will be randomized to one of the QuantiFERON®-CMV guided (intervention group) or standard protocol guided (control group) pre-emptive therapy. Weekly quantitative CMV PCR will be done during the first 4 weeks post-transplantation. Three weeks post-transplantation a second QuantiFERON®-CMV assay will be done in the intervention group and QuantiFERON®-CMV positive SOT recipients (CMV stimulation ≥0.2 IU/mL plus mitogen stimulation ≥0.5 IU/mL) will be followed with quantitative CMV PCR on months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, and 24. QuantiFERON®-CMV negative (CMV stimulation <0.2 IU/mL plus mitogen stimulation ≥0.5 IU/mL) and indeterminate (CMV stimulation <0.2 IU/mL plus mitogen stimulation <0.5 IU/mL) patients, as well as SOT recipients in the control group, will be undergone weekly CMV PCR up to the month 4 post-transplantation. Thereafter, CMV PCR will be done on months 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, and 24. At any point, the CMV viral load more than 1,000 IU/mL will be treated with valganciclovir or gancyclovir per protocol. All patients will be followed up to 4 years after transplantation or until death. |
To define the cumulative incidence of CMV infection (DNAemia) with a viral load of ≥2,000 IU/mL defined by positive PCR for CMV DNA in whole blood up to 12 months post-transplantation. To define the cumulative incidence of CMV disease (defined by clinical symptoms + presence of CMV DNAemia by quantitative PCR CMV DNA test). To define the graft and patients' survival and complications up to 36 months post-transplantation. |
| NCT02784756, Canada, 2016, NIH (48) | Adult kidney, kidney-pancreas, liver, or heart transplant recipient (Estimated number of participants is 200) | Quantiferon®-CMV assay | Phase III clinical trial with a single arm | Adult SOT recipients who are D+/R– or –/R+ and receive antithymocyte globulin induction therapy will include in this study. The duration of antiviral prophylaxis will define according to the results of Quantiferon®-CMV assay in specific time points during the study. More details are not accessible. |
To use Quantiferon®-CMV assay as a guide for the duration of primary CMV prophylaxis in SOT recipients. To define the number of SOT recipients with symptomatic CMV disease (Tissue invasive or viremia) during the first year after transplantation. |
| NCT03123627, Spain, 2016(49) | Adult kidney transplant recipients (Estimated number of participants is 105) | Quantiferon®-CMV assay | Phase III randomized Clinical Trial | Adult kidney transplant recipients who are CMV seropositive and Quantiferon®-CMV assay reactive at the time of transplantation and receive antithymocyte globulin induction therapy will be included in this study. The control group will receive a fixed duration of 3 months of antiviral prophylaxis after transplantation. The intervention group will receive antiviral prophylaxis and will be monitored with Quantiferon®-CMV assay at the days +15, +30, and +60 post-transplantation. The antiviral will be discontinued if the Quantiferon®-CMV assay is positive. Otherwise, antiviral will be continued up to the day +90 post-transplantation. Both groups will be followed 12 months post-transplantation for evidence of CMV disease. |
To define the incidence of CMV disease in kidney transplant recipients at 12 months after transplantation. To define the predictive value of Quantiferon®-CMV assay for the duration of anti-CMV antiviral prophylaxis. |
| NCT02538172, Switzerland, 2015, NIH (50) | Adult kidney and liver transplant recipients (Estimated number of participants is 200) | T-Track® CMV assay and Quantiferon-CMV® assays | Randomized controlled trial | Adult SOT recipients who are D+/R– or –/R+ and receive antithymocyte globulin induction therapy will be included in this study. The control group will receive a fixed duration of 3 or 6 months of antiviral prophylaxis. In the intervention group, SOT recipients will receive CMV antiviral prophylaxis and will be monitored with two different assays every 4 weeks from the second month after transplantation. Antiviral prophylaxis will be discontinued in T-Track® CMV assay positive patients and will be continued until the maximal duration of prophylaxis (3–6 months). After discontinuation of the antiviral prophylaxis, SOT recipients in both groups will be followed up in for evidence of CMV replication up to 12 months after transplantation. If viral replication detects by PCR, standard treatment will be done according to local guidelines. |
To use CMI as a guide for the duration of primary CMV prophylaxis in SOT recipients. To define the incidence of CMV infection and CMV viremia in SOT recipients during the first year after transplantation. To define graft survival during the study, follow up. |