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

Launched by UNIVERSITY HOSPITAL, GRENOBLE · Mar 25, 2024

Keywords

ClinConnect Summary

The QUANTIFOT clinical trial is studying how a specific blood test, called the QuantiFERON-CMV (QF-CMV), can help identify solid organ transplant recipients who have a mild cytomegalovirus (CMV) infection but may not need antiviral treatment. CMV is a common virus that can cause serious health issues after an organ transplant, so it's important to find out which patients are at high risk. The trial will include adult participants who have recently undergone a heart, kidney, liver, or lung transplant and have a detectable CMV viral load, but are not showing any symptoms of illness.

Participants in the trial can expect to provide blood samples at various points after their initial test. Depending on which group they are placed in, doctors may or may not have access to the test results when deciding on treatment. The study will monitor participants for any changes in their CMV levels and watch for potential side effects from antiviral medications. To be eligible, individuals must be at least 18 years old and have a confirmed CMV infection without symptoms, among other criteria. This trial aims to improve how doctors manage CMV infections after transplants and reduce unnecessary treatments that may have side effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years.
• • Solid organ transplant recipient (heart, kidney, liver and lung)
• * Detectable CMV viral load between 1,000 and 15,000 IU/mL (including 2 borderline values):
• • Asymptomatic (no fever or organ dysfunction) ;
• • Occurrence within 2 years of transplantation in the absence of primary post-transplant anti-CMV prophylaxis;
• • Or within 2 years of discontinuation of primary post-transplant anti-CMV prophylaxis if such prophylaxis was used.
• • Having signed an informed consent form.
• • Affiliated to a social security scheme.
• Exclusion Criteria:
• • Presence of anti-Herpesviridae treatment when CMV replication is detected (\[val\]aciclovir, \[val\]ganciclovir, foscarnet, cidofovir, letermovir, maribavir, anti-CMV immunoglobulins, cidofovir, brincidofovir).
• • Pregnant or breast-feeding women.
• • Persons under guardianship or trusteeship.
• • Subjects under administrative or judicial supervision.
• • Subject unable to be contacted in case of emergency.