Use of QuantiFERONae CMV to Guide Treatment Decisions in Asymptomatic Cytomegalovirus Infection After Solid Organ Transplant

What this Trial Is About

Researchers are studying the use of the QuantiFERON-CMV (QF-CMV) test to help decide if asymptomatic solid organ transplant recipients with a low to moderate cytomegalovirus (CMV) viral load need antiviral treatment. CMV infection can be severe in transplant patients, but available treatments often cause side effects. This study aims to see if measuring the body's CMV-specific T cell immunity with QF-CMV can identify patients who may not require antiviral therapy, improving care and reducing unnecessary drug use. Participants are solid organ transplant recipients with a CMV viral load between 1,000 and 15,000 IU/mL and no symptoms. They will be randomly assigned to two groups: one where the QF-CMV test result is shared with their doctor, and one where it is not. Doctors in the first group are advised not to treat if the test is positive, while in the second group, treatment decisions follow usual care. Blood viral load, kidney function, blood counts, and potassium levels will be monitored at several points up to 40 days after the test. Participants will have blood samples taken at inclusion and then at 5 to 12 days, 12 to 26 days, and 19 to 40 days after the initial test. The main outcome is whether the CMV infection is uncontrolled at 5 to 12 days, defined by viral load thresholds or onset of CMV disease. Secondary outcomes include monitoring for side effects from antiviral drugs such as anemia or kidney problems. The study will help understand if QF-CMV testing can safely guide treatment decisions for transplant patients with CMV infection.

Quantiferon CMV to Identify Treatment Need for Asymptomatic CMV Infection After Solid Organ Transplant (QUANTIFOT)