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

NCT ID: NCT04377139

Last Updated: 2020-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-30

Study Completion Date

2022-06-30

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.

Detailed Description

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Conditions

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Lung Transplant; Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Prophylaxis

Those LTR receiving prophylaxis against CMV

Prophylaxis

Intervention Type PROCEDURE

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

Preemptive

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Oscar Len, MD

Role: CONTACT

+34934896090

Other Identifiers

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PR(AG)54/2020

Identifier Type: -

Identifier Source: org_study_id

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