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

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ClinicalTrials.gov Identifier: NCT04377139
Recruitment Status : Not yet recruiting
First Posted : May 6, 2020
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

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.


Condition or disease Intervention/treatment
Lung Transplant; Complications Procedure: Prophylaxis Procedure: Preemptive

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational, Epidemiological, Retrospective Study of the Management of CMV Infection in a Cohort of Patients Receiving Lung Transplantation in Spain
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022


Group/Cohort Intervention/treatment
Prophylaxis
Those LTR receiving prophylaxis against CMV
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 therapy
Those LTR receiving preemptive therapy against CMV
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




Primary Outcome Measures :
  1. CMV infection and/or disease [ Time Frame: Two-year follow-up ]
    Incidence


Secondary Outcome Measures :
  1. Graft rejection both acute or CLAD [ Time Frame: Two-year follow-up ]
    Incidence



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All those LTR performed in Spain during the study period
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377139


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

Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT04377139    
Other Study ID Numbers: PR(AG)54/2020
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
cytomegalovirus
Additional relevant MeSH terms:
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Infection