Actively Recruiting
Breakthrough CMV Lung Transplant -Multicentre
Led by University of Alberta · Updated on 2026-03-16
40
Participants Needed
1
Research Sites
357 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Breakthrough CMV Lung Transplant -Multicentre
Who Can Participate
Eligibility Criteria
You may qualify if you...
- CMV seronegative recipients of CMV seropositive donor lung transplantation.
- Age 18 years or older.
- Receiving antiviral prophylaxis with valganciclovir for 6 or 12 months after transplantation as per local protocol.
- Monitoring of CMV DNAemia after prophylaxis for at least 12 weeks according to local protocol.
- Signed informed consent to participate.
You will not qualify if you...
- Known allergy to ganciclovir or valganciclovir.
- Neutropenia (less than 1.0) before transplantation.
- Lung transplantation from a living donor.
- Lung re-transplantation.
- Pre-transplant immunodeficiency.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
Research Team
D
Dr. Carlos Cervera
CONTACT
K
Kimberly J Robertson, BSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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