Status:
RECRUITING
Breakthrough CMV Lung Transplant -Multicentre
Lead Sponsor:
University of Alberta
Conditions:
Cytomegalovirus Infections
Eligibility:
All Genders
18+ years
Brief 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...
Detailed Description
Purpose: The purpose of this study is to learn more about the rate of CMV breakthrough in lung transplant patients who are CMV mismatched and receiving prophylaxis. The rates of negative side effects...
Eligibility Criteria
Inclusion
- 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
- Known allergy to ganciclovir or valganciclovir.
- Neutropenia (\< 1.0) pre-transplantation.
- Living-donor lung transplantation.
- Lung re-transplantation.
- Pre-transplant immunodeficiency
Key Trial Info
Start Date :
January 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04439916
Start Date
January 25 2021
End Date
December 1 2025
Last Update
January 23 2025
Active Locations (1)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7