Breakthrough CMV Lung Transplant -Multicentre

Recruiting now

Conditions studied: Cytomegalovirus Infections

In brief

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.

Key facts

Study ID

NCT04439916

Run by

University of Alberta

People needed

40

Starts

2021-01-25

Expected to finish

2027-12-01

Last updated by the study team

2026-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Known allergy to ganciclovir or valganciclovir.
• Neutropenia (< 1.0) pre-transplantation.
• Living-donor lung transplantation.
• Lung re-transplantation.
• Pre-transplant immunodeficiency

Where it is running

• University of Alberta Hospital — Edmonton, Alberta, Canada (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.