Breakthrough CMV Lung Transplant -Multicentre

Launched by UNIVERSITY OF ALBERTA · Jun 17, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating how often patients who receive a lung transplant experience a breakthrough infection from cytomegalovirus (CMV) while taking a preventive medication called Valganciclovir. CMV can be a serious infection for lung transplant patients, especially when the patient has never been exposed to it before (CMV negative) and their donor has had previous exposure (CMV positive). The study aims to find out how common these breakthrough infections are during the recommended 6 to 12 months of treatment, as well as to monitor any side effects from the medication.

To be eligible for this trial, participants must be adults aged 18 or older who have received a lung transplant from a donor with a history of CMV infection. They must also be taking the antiviral medication as instructed after their transplant and have their CMV levels monitored for at least 12 weeks. It's important to know that participants will need to provide informed consent and that certain conditions, like allergies to the medication or specific health issues, may prevent someone from joining the study. By participating, patients can help researchers better understand CMV infections in lung transplant recipients and improve treatment strategies.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • CMV seronegative recipients of CMV seropositive donor lung transplantation.
• • Age 18 years or older.
• • Receipt of antiviral prophylaxis with valganciclovir as per local protocol with a duration of 6 or 12 months after transplantation.
• • Monitoring of CMV DNAemia post-prophylaxis for at least 12 weeks as per local protocol.
• • Signed informed consent.
• Exclusion Criteria:
• • Known allergy to ganciclovir or valganciclovir.
• • Neutropenia (\< 1.0) pre-transplantation.
• • Living-donor lung transplantation.
• • Lung re-transplantation.
• • Pre-transplant immunodeficiency