CMV infection and CMV disease in high-risk lung transplant recipients cytomegalovirus, lung transplant
Conditions
Interventions
For high-risk lung transplant recipients (defined as CMV D+/R- or those with recurrent CMV disease), prophylactic administration of anti-CMV agents (valganciclovir or letermovir) will be continued bey
D019072
valganciclovir, letermovir
Sponsors
Hirama Takashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who undergo lung transplantation between August 1, 2024, and July 31, 2028, and provide written informed consent - No restrictions on age, sex, donor type (brain-dead or living), surgical procedure (single or bilateral), or underlying disease - If the patient lacks sufficient decision-making capacity, informed consent shall be obtained from a legally acceptable representative - For patients under 18 years of age, informed consent shall be obtained from a legally acceptable representative, and assent shall be obtained from the patient using age-appropriate explanations
Exclusion criteria
Exclusion criteria: 1) Individuals who do not provide written informed consent 2) Individuals deemed inappropriate for inclusion by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the impact of extended prophylaxis of anti-CMV agents in high-risk lung transplant recipients on the incidence of CMV infection (PCR-positive) at 2 years post-transplant, in comparison with moderate-risk recipients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical outcomes will include the incidence of CMV disease, defined as PCR-positive CMV infection with clinical symptoms, and CMV-related mortality. Regarding safety, the incidence of adverse events such as neutropenia associated with valganciclovir, and the emergence of drug-resistant CMV strains will be assessed. Economic outcomes will include the cumulative total medical costs related to CMV management during the observation period. In addition, comparisons will be made between high-risk and low-risk recipients in terms of CMV infection rate, recurrence rate, incidence of CMV disease, and frequency of adverse events. The association between CMV infection or disease and graft lung function will also be evaluated. A similar analysis will be performed comparing high-risk and intermediate-risk recipients. Furthermore, in the high-risk CMV group, a comparison with historical cases will be conducted to investigate associations with long-term prognosis. | — |
Contacts
Public ContactTakashi Hirama
Tohoku University Hospital
Outcome results
None listed