RecruitingNCT04439916

Breakthrough CMV Lung Transplant -Multicentre

Breakthrough CMV DNAemia in CMV Seronegative Recipients of CMV Seropositive Lung Transplantation During Antiviral Prophylaxis With Valganciclovir. A Pilot Study.


Sponsor

University of Alberta

Enrollment

40 participants

Start Date

Jan 25, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

Cytomegalovirus (CMV) infection is the most common opportunistic infection in lung transplantation leading to direct and indirect effects that can result in life threatening complications. The risk of CMV infection is highest when the recipient of the transplant has never been in contact with CMV (negative immunity) and the donor had previous contact with CMV (positive immunity). This is called CMV mismatch. For these lung transplant patients 6 to 12 months of prophylaxis with an antiviral called Valganciclovir is recommended. This antiviral can cause side effects like bone marrow toxicity and decrease in immune cells which can result in temporarily having to stop the treatment. Starting and stopping the prophylaxis may result in the CMV becoming resistant to the medication. While taking the prophylaxis it is possible to have a breakthrough of the CMV, this is often due to the development of resistance to the antiviral. The purpose of this study is to learn more about the rate of CMV breakthrough while on prophylaxis after lung transplantation in patients who are CMV mismatch. The investigators will also look at the rates of negative side effects caused by antiviral prophylaxis in this population.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at a phenomenon called "breakthrough CMV infection" in lung transplant recipients. Cytomegalovirus (CMV) is a very common virus that is harmless in healthy people but can cause serious illness in immunosuppressed patients. When a CMV-negative person receives a lung from a CMV-positive donor, they are at very high risk of developing CMV disease. Standard practice is to give prophylactic antiviral medication (valganciclovir) for 6 or 12 months after transplant. However, some patients develop CMV infection after this preventive treatment ends — called breakthrough infection — and this study aims to understand who is at risk and why. Participants are followed after their transplant, with regular monitoring for CMV. Researchers will look at factors like immune responses, viral characteristics, and medication adherence that predict breakthrough infection. Understanding this could lead to better-targeted prevention strategies. You may be eligible if: - You received a lung transplant from a CMV-positive donor but are CMV-negative yourself - You are 18 or older - You received the full course of valganciclovir prophylaxis as per your transplant center's protocol - You had CMV monitoring after your prophylaxis ended for at least 12 weeks - You have given signed informed consent You may NOT be eligible if: - You have a known allergy to ganciclovir or valganciclovir - You had low neutrophil count before the transplant - You had a living-donor or re-transplant lung transplant - You had a pre-existing immunodeficiency condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

University of Alberta Hospital

Edmonton, Alberta, Canada

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NCT04439916


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