Monitoring CMV infections in lung transplant patients
Official title: Breakthrough CMV DNAemia in CMV Seronegative Recipients of CMV Seropositive Lung Transplantation During Antiviral Prophylaxis With Valganciclovir. A Pilot Study.
Run by University of Alberta · NCT04439916 · Data updated 2026-11-12
This study looks at how well antiviral medication works to prevent CMV infections in lung transplant patients who might be at risk, while also checking for any side effects from the treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Status | Recruiting |
| Started | January 25, 2021 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | March 16, 2026 |
| Trial ID | NCT04439916 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include CMV seronegative lung transplant recipients from CMV seropositive donors who are 18 years or older and receiving antiviral prophylaxis.
✕Probably not a fit
Patients with known allergies to ganciclovir or valganciclovir, pre-existing neutropenia, or those undergoing living-donor or re-transplantation will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to investigate the rate of cytomegalovirus (CMV) breakthrough infections in lung transplant patients who are mismatched for CMV immunity and are receiving antiviral prophylaxis with valganciclovir. It will also monitor the negative side effects associated with this prophylaxis, such as bone marrow toxicity and the potential for drug resistance. The study will evaluate the frequency of CMV DNAemia and the impact of treatment-related complications on patient outcomes. The findings will help inform future prophylactic strategies and improve patient safety.
Why it matters
Potential benefit: If successful, this study could lead to improved management of CMV infections in lung transplant patients, reducing complications and enhancing patient safety.
How similar studies have gone: While this study addresses a known issue in lung transplantation, the specific approach of monitoring CMV breakthrough in this context has not been extensively tested, making it a novel investigation.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of Alberta Hospital
Edmonton, Alberta, Canada Recruiting
Study contacts
- Principal investigator: Dr. Carlos Cervera — University of Alberta
- Study coordinator: Dr. Carlos Cervera
- Email: cerveraa@ualberta.ca
- Phone: 780-492-5346
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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CMV-specific T cells after CMV reactivation in adults after HSCT
This study tests CMV-specific immune recovery in adults who have their first CMV reactivation after an allogeneic HSCT to see how CMV-specific T cells change over time.
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Biomarkers linked to congenital CMV using newborn blood spots
Researchers will test protein and RNA markers in dried blood spots from newborns to see if they can identify congenital CMV sequelae early.
-
T-cell–guided letermovir stopping after allogeneic stem cell transplant
This tests whether using a CMV-specific T-cell blood test to decide when adult CMV-positive patients can stop letermovir after allogeneic stem cell transplant keeps them protected while avoiding unnecessary drug exposure.
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Family-donor viral CTLs plus standard care vs standard care alone for refractory ADV or CMV infection after stem cell transplant
This study tests whether using family-donor virus-specific CTLs in addition to usual treatment helps children, teens, and young adults with hard-to-treat CMV or adenovirus infections after a stem cell transplant.
-
CMV-specific immunoglobulin to prevent CMV problems in children getting allogeneic stem cell transplants
Doctors will try giving CMV-specific immunoglobulin to children having allogeneic stem cell transplants to prevent CMV reactivation and related transplant complications.
-
R-MVST cell therapy for viral infections in children and young adults
This will try giving rapidly generated virus-specific T cells (R-MVST) to children and young adults whose weakened immune systems have recurrent or treatment-resistant infections with EBV, CMV, adenovirus, or BK virus.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.