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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lung Transplant; Complications

Intervention / Treatment
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* Procedure: Prophylaxis
* Procedure: Preemptive


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prophylaxis<br>Those LTR receiving prophylaxis against CMV | Procedure: Prophylaxis<br>* 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<br>|
| Preemptive therapy<br>Those LTR receiving preemptive therapy against CMV | Procedure: Preemptive<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CMV infection and/or disease | Incidence | Two-year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft rejection both acute or CLAD | Incidence | Two-year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cytomegalovirus