HCMV Breakthrough Infections During Letermovir Prophylaxis

Launched by FONDAZIONE IRCCS POLICLINICO SAN MATTEO DI PAVIA · Mar 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how to better monitor infections caused by the cytomegalovirus (HCMV) in patients who have received a stem cell transplant and are taking a medication called letermovir (LTV) to prevent these infections. The researchers want to see if testing for HCMV DNA in blood after treating it with an enzyme (called DNAse) can help identify real infections more accurately. The aim is to reduce unnecessary antiviral treatments, which can have side effects, by ensuring that only patients with true infections stop taking LTV and start different medications.

To be eligible for this study, participants must be over 18 years old, have had an allogeneic stem cell transplant (where the donor and recipient are different), and have tested positive for a specific antibody (HCMV IgG) before the transplant. Participants will be randomly assigned to one of two groups: one group will have their blood tested for HCMV DNA without treatment, while the other group will have their blood treated with DNAse before testing. Throughout the study, patients will be monitored for any side effects and the researchers will ensure that the new testing strategy does not increase the risk of HCMV disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age\>18 years.
• • Allogeneic hematopoietic stem cell transplant.
• • HCMV IgG seropositivity before transplant
• • Written informed consent.
• • LTV prophylaxis administration
• Exclusion Criteria:
• • Age \<18 years.
• • Inability to comply with the requirements of the protocol.