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Breakthrough CMV Lung Transplant -Multicentre

Recruitingn/aAges 18 Years - anyAllUniversity of Alberta
NCT04439916 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 developmen

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
University of Alberta Hospital
Edmonton, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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