Study of the Pathogenicity and Humoral Immune Response Induced by BK Virus in Lung Transplant Recipients (BKV-Pneumo)

November 12, 2019 updated by: University Hospital, Strasbourg, France

BK virus (BKV) is a ubiquitous virus that infects more than 80% of the population. In case of immunosuppression, BKV can replicate and induce nephropathies in renal transplant recipients or haemorrhagic cystitis in bone marrow transplant recipients. The disruption of the balance between BKV replication and immune control is considered the key element in the development of these pathologies. During lung transplantation, patients undergo intense immunosuppression that favors the reactivation of persistent viruses such as EBV, CMV and probably BKV. Although the data on EBV and CMV reactivation are very clear and allow optimal management, the prevalence of BKV replication and its clinical impact in lung transplant recipients remains unknown at this time.

The aim of this study is to know the incidence and clinical impact of BKV replication in lung transplant recipients. Moreover, the results will help to better understand the interaction between the virus and his host, with a focus on the humoral and cellular immune response against BKV. The results could possibly enable to define predictive markers of BKV replication and of its evolution.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Les Hopitaux Universitaires de Strasbourg
        • Contact:
        • Principal Investigator:
          • Samira FAFI-KREMER
        • Sub-Investigator:
          • Floriane GALLAIS
        • Sub-Investigator:
          • Morgane SOLIS
        • Sub-Investigator:
          • Romain KESSLER
        • Sub-Investigator:
          • Eva CHATRON
        • Sub-Investigator:
          • Tristan DEGOT
        • Sub-Investigator:
          • Marianne RIOU
        • Sub-Investigator:
          • Michele PORZIO
        • Sub-Investigator:
          • Armelle SCHULLER
        • Sub-Investigator:
          • Sandrine HIRSCHI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Lung transplant recipients between 30 June 2018 and 31 December 2022 at the University Hospital of Strasbourg

Description

Inclusion criteria:

  • Lung transplant recipients in Strasbourg University Hospital between 30 June 2018 and 31 December 2022
  • Male or female patients, age over 18 years
  • Patient having provided informed written consent to take part in the study
  • Patient affiliated to Social Security

Exclusion criteria:

  • Patient deprived of liberty, by judicial or administrative decision
  • Patient under legal guardianship
  • Impossibility to give complete information about this study to the patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BKV viral load in urine (viruria) and in plasma (viremia)
Time Frame: 3 years
In cases of positive viral load, the viral genome will be sequenced to identify the replicative genotype.
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Quantification of anti-BKV neutralizing antibodies
Time Frame: 3 years
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of BKV specific T lymphocytes
Time Frame: 3 years
3 years
TTV viral load in plasma
Time Frame: 3 years
Evaluation of the viral load of TTV (reflection of global immunosuppression) or its genotype (established by sequencing).
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

June 1, 2027

Study Registration Dates

First Submitted

November 12, 2019

First Submitted That Met QC Criteria

November 12, 2019

First Posted (Actual)

November 15, 2019

Study Record Updates

Last Update Posted (Actual)

November 15, 2019

Last Update Submitted That Met QC Criteria

November 12, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 7547

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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