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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Transplant; Complications
• Intervention / Treatment: Procedure: Prophylaxis; Procedure: Preemptive

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

• Study Contact: Name: Oscar Len, MD; Phone Number: +34934896090; Email: oscar.len@vhir.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All those LTR performed in Spain during the study period

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prophylaxis; Those LTR receiving prophylaxis against CMV	Procedure: Prophylaxis; 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
Preemptive therapy; Those LTR receiving preemptive therapy against CMV	Procedure: Preemptive; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: May 3, 2020
• First Submitted That Met QC Criteria: May 3, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: cytomegalovirus
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: PR(AG)54/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No