Cytomegalovirus Viraemia Clinical Trial
Official title:
Cell Mediated Immunity as a Guide for Secondary Prophylaxis in SOT Patients With CMV Infection
This study will evaluate whether a test for Cytomegalovirus (CMV) specific cell-mediated immunity can be used to determine whether patients who complete a course of therapy for CMV viremia need secondary antiviral prophylaxis. Subjects that have negative CMV CMI will receive antiviral prophylaxis for 2 months and those with positive CMV CMI will have their prophylaxis stopped.
Cytomegalovirus (CMV) is the most important infection in transplant patients and it is a
common cause of illness in patients who have undergone a transplant. Serious infections due
to CMV can affect many parts of the body including the lungs, the gut, and the liver; when
CMV infection becomes serious enough to cause symptoms, it is called CMV disease. Some
patients require treatment while others will clear the virus on their own.
QuantiFERON-CMV (QFT-CMV) is a blood test that measures CMV-specific cell-mediated immunity.
This test was able to predict that patients with low cell-mediated immunity are at greater
risk for developing CMV disease. In this study, QFT-CMV will be used to make a decision
regarding CMV treatment. The QFT-CMV test will be performed at the first detection of CMV, at
end of antiviral therapy and one month post-therapy. The end-of-therapy results will be
available to clinicians and study investigators within one week of collection. Based on the
result, a decision will be made to continue with prolonged antiviral therapy. Patients that
show weak cell-mediated immunity against CMV will be given secondary antiviral prophylaxis,
while patients with good cell-mediated immunity will have their therapy stopped. Patients
will continue to be monitored three months after the last QFT-CMV test for recurrent CMV
viremia.
This study will also attempt to evaluate the predictive value of the QuantiFERON-Monitor
(QFT-Monitor) assay. QFT-Monitor is a recently developed non-pathogen specific immune assay:
it is based on immune activation of both innate and adaptive immunity. The investigators
hypothesize that stimulation of both the innate and adaptive immunity may predict global
immune function and also be predictive of CMV reactivation. The investigators plan to perform
the QFT-Monitor assay in parallel to the QFT-CMV test to determine the test characteristics
and cut-off values in predicting global immune function. This test will be collected and
tested in batches. Therefore, the results will not influence clinical decisions.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02784756 -
Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients
|
N/A | |
| Unknown status |
NCT01397058 -
Reactivation of CMV Infection in Immunocompetent Patients Under Severe Stress
|
N/A |