Impact of Infectious Diseases Consultation on Vaccination Coverage Among People Waiting for a Kidney Transplant at the Clermont-Ferrand Hospital

Overview

Solid-organ transplant patients are at increased risk of infectious diseases. Among this population, infectious diseases may be life-threatening or lead to graft rejection. Their prevention is an important challenge. Despite specific national recommendations, vaccination is underutilized. That is why we propose a dedicated infectious diseases consultation during pre-kidney transplantation assessment.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2022

Detailed Description

The main objective of this study is to impove vaccine coverage before kidney transplantation. Enrollment was based on the waiting list for a kidney transplant. Patients newly listed are invited to participate by the transplant team (nephrology department) ; for those that are already registered, a notification letter is sent to their home. All patients included must : – complete a health questionnaire – take a blood test at day 0 : viral, bacterial and parasitic serologies, QuantiFERON-TB – take a chest X-ray and dental panoramic Patients randomized in interventional group will be seen in specific infectious diseases consultation at Clermont Ferrand Hospital. A letter of recommendations is sent to nephrologist for patients randomized in group control. The primary study endpoint (immunization coverage) is evaluated at 6 months.

Interventions

  • Other: Specific infectious diseases consultation
    • Specific infectious diseases consultation at Clermont Ferrand Hospital with a specialist doctor : Update vaccinations Advice to travelers Diagnostic and treatment of latent tuberculosis infection

Arms, Groups and Cohorts

  • Experimental: Stronger pre-transplant check-up
    • routine patient management + specific infectious diseases consultation
  • No Intervention: Standard pre-transplant check-up
    • routine patient management + letter sent to nephrologist

Clinical Trial Outcome Measures

Primary Measures

  • Vaccination coverage
    • Time Frame: Month 6
    • The percentage of fully immunized patients according to the Recommendations of High Council for public Health

Secondary Measures

  • Infectious complications
    • Time Frame: within the 6 months of the transplantation
    • Infectious diseases which require special management (hospitalization, anti-infective treatments)
  • Mortality
    • Time Frame: Month 6
    • Mortality after kidney transplantation

Participating in This Clinical Trial

Inclusion Criteria

  • Patient over 18 – On the waiting list for kidney transplantation at Clermont-Ferrand – Free and informed consent – Affiliation to a social security system Exclusion Criteria:

  • Patient under 18 – Protected adults (individuals under guardianship by court order – Pregnant and nursing women – Prior graft (solid organs or hematopoietic stem cells) – Absence of consent

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Clermont-Ferrand
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Olivier Lesens, Principal Investigator, CHU de Clermont-Ferrand
  • Overall Contact(s)
    • Lise LACLAUTRE, +334 73 754 963, promo_interne_drci@chu-clermontferrand.fr

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