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

Lung Transplant; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04377139
• Other study ID #: PR(AG)54/2020
• Status: Not yet recruiting
• Start date: June 2020
• Est. completion date: June 2022

Study information

• Verified date: May 2020
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Oscar Len, MD
• Phone: +34934896090
• Email: oscar.len[@]vhir.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Lung Transplant; Complications

Intervention

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
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CMV infection and/or disease	Incidence	Two-year follow-up
Secondary	Graft rejection both acute or CLAD	Incidence	Two-year follow-up