Skip to content

Management of Cytomegalovirus (CMV) Infection in Lung Transplant Recipients (LTR)

Observational, Epidemiological, Retrospective Study of the Management of CMV Infection in a Cohort of Patients Receiving Lung Transplantation in Spain

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04377139
Enrollment
1500
Registered
2020-05-06
Start date
2020-06-30
Completion date
2022-06-30
Last updated
2020-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Transplant; Complications

Keywords

cytomegalovirus

Brief summary

Background: Lung transplant recipients (LTR) have the highest risk of CMV infection. CMV pneumonitis, lymphocytic bronchitis, and detection of CMV DNA in bronchoalveolar lavage fluid are independent risk factors for the development of chronic lung allograft dysfunction (CLAD). However, to demonstrate the clinical impact of the indirect effects of CMV, it is necessary to conduct studies with a very large sample size. Hypothesis: The different current preventive strategies for CMV infection in LTR and their clinical application on a daily basis impact on the development of direct and indirect effects of CMV in this population. Objectives: To study the effect of CMV infection on LTR in relation to current preventive strategies in terms of: * The incidence of acute and chronic rejection * The incidence of other opportunistic infections * The incidence of neoplastic disease, especially, post-transplant lymphoproliferative disease * Patient and graft survival Methods: Multicenter, retrospective, cohort study. Consecutive inclusion of all adult lung transplant recipients from 2013 to 2017 with 2 years of follow-up. The investigators will collect and analyze the main clinical and microbiological variables in order to respond to the objectives of the study. Relevance: Knowing in detail the current epidemiology of CMV infection in LTR and its subsequent influence on both mortality and the presence of different complications, could allow improving the management of these patients in the future.

Interventions

PROCEDUREProphylaxis

The intervention consists of analyzing the differences in the evolution of lung transplant recipients in relation to the intervention of prophylaxis or preemptive therapy against CMV in LTR

PROCEDUREPreemptive

The intervention consists of analyzing the differences in the evolution of lung transplant recipients in relation to the intervention of prophylaxis or preemptive therapy against CMV in LTR

Sponsors

Hospital Universitari Vall d'Hebron Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

· Survival \> 1 month post-transplant • High to moderate risk patients to develop CMV disease by means of pre-transplant CMV serology: * Donor positive to recipient negative * Recipient positive independently of donor serology

Exclusion criteria

* Survival \< 1 month after procedure * Low risk serology to develop CMV disease: both donor and recipient seronegative

Design outcomes

Primary

MeasureTime frameDescription
CMV infection and/or diseaseTwo-year follow-upIncidence

Secondary

MeasureTime frameDescription
Graft rejection both acute or CLADTwo-year follow-upIncidence

Contacts

Primary ContactOscar Len, MD
oscar.len@vhir.org+34934896090

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026