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

NCT04377139 | Unknown

• 1 other identifier: PR(AG)54/2020
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lung Transplant; Complications

Keywords

cytomegalovirus

Outcome Measures

Primary Outcomes (1)

• CMV infection and/or disease

  Incidence

  Two-year follow-up

Secondary Outcomes (1)

• Graft rejection both acute or CLAD

  Two-year follow-up

Study Arms (2)

Prophylaxis

Those LTR receiving prophylaxis against CMV

Procedure: Prophylaxis

Preemptive therapy

Those LTR receiving preemptive therapy against CMV

Procedure: Preemptive

Interventions

Prophylaxis 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

Prophylaxis

Preemptive 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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All those LTR performed in Spain during the study period

You may qualify if:

• · 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

You may not qualify if:

• Survival \< 1 month after procedure
• Low risk serology to develop CMV disease: both donor and recipient seronegative

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Central Study Contacts

Oscar Len, MD

CONTACT

+34934896090; oscar.len@vhir.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2020
• First Posted: May 6, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: May 11, 2020

Record last verified: 2020-05