Monitoring CMV infections in lung transplant patients
Breakthrough CMV DNAemia in CMV Seronegative Recipients of CMV Seropositive Lung Transplantation During Antiviral Prophylaxis With Valganciclovir. A Pilot Study.
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 |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT04439916 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include CMV seronegative lung transplant recipients from CMV seropositive donors who are 18 years or older and receiving antiviral prophylaxis.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Edmonton, Alberta
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.