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

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Recruiting
CT.gov ID
NCT04791098
Collaborator
(none)
150
1
2
66.5
2.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Specific infectious diseases consultation
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Impact of Infectious Diseases Consultation on Vaccination Coverage Among People Waiting for a Kidney Transplant at the Clermont-Ferrand Hospital
Actual Study Start Date :
Sep 16, 2020
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Apr 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stronger pre-transplant check-up

routine patient management + specific infectious diseases consultation

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

No Intervention: Standard pre-transplant check-up

routine patient management + letter sent to nephrologist

Outcome Measures

Primary Outcome Measures

  1. Vaccination coverage [Month 6]

    The percentage of fully immunized patients according to the Recommendations of High Council for public Health

Secondary Outcome Measures

  1. Infectious complications [within the 6 months of the transplantation]

    Infectious diseases which require special management (hospitalization, anti-infective treatments)

  2. Mortality [Month 6]

    Mortality after kidney transplantation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Clermont-Ferrand Clermont-Ferrand France 63000

Sponsors and Collaborators

  • University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Olivier Lesens, CHU de Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT04791098
Other Study ID Numbers:
  • RBHP 2019 LESENS
  • 2019-A02304-53
First Posted:
Mar 10, 2021
Last Update Posted:
Mar 10, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Clermont-Ferrand
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2021