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Status unknownNCT04377139Updated May 11, 2020

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

An observational study in Lung Transplant; Complications, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Status unknown. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-05-11.

Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Observational

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,500
Ages
18 Years to 100 Years
Sex
All
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Study 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.

02

Conditions studied

  • Lung Transplant; Complications

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Keywords

  • cytomegalovirus
03

In context

Infections

6,686 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 240 across 2,136 observational studies indexed under Infections.

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Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All those LTR performed in Spain during the study period

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

Exclusion Criteria:

  • Survival \< 1 month after procedure
  • Low risk serology to develop CMV disease: both donor and recipient seronegative
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Prophylaxis

    Those LTR receiving prophylaxis against CMV

    Procedure: Prophylaxis

  • Preemptive therapy

    Those LTR receiving preemptive therapy against CMV

    Procedure: Preemptive

Interventions

  • ProcedureProphylaxis

    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

  • ProcedurePreemptive

    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

06

What researchers measure

Primary outcomes

  1. CMV infection and/or disease

    Incidence

    Time frame: Two-year follow-up

Secondary outcomes

  1. Graft rejection both acute or CLAD

    Incidence

    Time frame: Two-year follow-up

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04377139
Lead sponsor
Hospital Universitari Vall d'Hebron Research Institute
Responsible party
Sponsor
First posted
May 6, 2020
Start date
Jun 2020 (estimated)
Primary completion
Jun 2022 (estimated)
Completion
Jun 2022 (estimated)
Last update
May 11, 2020

Study contacts

Oscar Len, MD
Contact
oscar.len@vhir.org
+34934896090

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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