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

March 8, 2021 updated by: University Hospital, Clermont-Ferrand
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • Recruiting
        • CHU de Clermont-Ferrand

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

Description

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

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

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

University Hospital, Clermont-Ferrand

Investigators

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

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 (ACTUAL)

September 16, 2020

Primary Completion (ANTICIPATED)

March 1, 2022

Study Completion (ANTICIPATED)

April 1, 2026

Study Registration Dates

First Submitted

March 8, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (ACTUAL)

March 10, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBHP 2019 LESENS
  • 2019-A02304-53 (OTHER: ANSM)

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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