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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04377139
Other study ID # PR(AG)54/2020
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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