NCT04439916 Breakthrough CMV Lung Transplant -Multicentre
| NCT ID | NCT04439916 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alberta |
| Condition | Cytomegalovirus Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-01-25 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2021-01-25 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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
Contact & Investigator
Dr. Carlos Cervera
PRINCIPAL INVESTIGATOR
University of Alberta
Frequently Asked Questions
Who can join the NCT04439916 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cytomegalovirus Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04439916 currently recruiting?
Yes, NCT04439916 is actively recruiting participants. Contact the research team at cerveraa@ualberta.ca for enrollment information.
Where is the NCT04439916 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT04439916 clinical trial?
NCT04439916 is sponsored by University of Alberta. The principal investigator is Dr. Carlos Cervera at University of Alberta. The trial plans to enroll 40 participants.