About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patient deprived of liberty, by judicial or administrative decision
Patient under legal guardianship
Impossibility to give complete information about this study to the patient
Trial population
Lung transplant recipients between 30 June 2018 and 31 December 2022 at the University Hospital of Strasbourg
Trial design
Cohort
Prospective
Treatments tested in this trial
Transplant patients
GeneticStudy the specific immunity against Polyomavirus
Treatment groups
Trial outcomes
Primary outcomes
BKV viral load in urine (viruria) and in plasma (viremia)
In cases of positive viral load, the viral genome will be sequenced to identify the replicative genotype.
Secondary outcomes
Quantification of anti-BKV neutralizing antibodies
Other outcomes
Quantification of BKV specific T lymphocytes
TTV viral load in plasma
Evaluation of the viral load of TTV (reflection of global immunosuppression) or its genotype (established by sequencing).
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: