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

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ClinicalTrials.gov Identifier: NCT04791098
Recruitment Status : Recruiting
First Posted : March 10, 2021
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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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
Kidney Transplantation Other: Specific infectious diseases consultation Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 16, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : April 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Vaccination coverage [ Time Frame: Month 6 ]
    The percentage of fully immunized patients according to the Recommendations of High Council for public Health


Secondary Outcome Measures :
  1. Infectious complications [ Time Frame: within the 6 months of the transplantation ]
    Infectious diseases which require special management (hospitalization, anti-infective treatments)

  2. Mortality [ Time Frame: Month 6 ]
    Mortality after kidney transplantation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04791098


Contacts
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Contact: Lise LACLAUTRE +334 73 754 963 promo_interne_drci@chu-clermontferrand.fr

Locations
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France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63000
Contact: Lise LACLAUTRE    +33473754963    promo_interne_drci@chu-clermontferrand.fr   
Principal Investigator: Olivier Lesens         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Olivier Lesens CHU de Clermont-Ferrand
More Information
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT04791098    
Other Study ID Numbers: RBHP 2019 LESENS
2019-A02304-53 ( Other Identifier: ANSM )
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021

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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:
Immunization Coverage
Transplant Recipient
Transplantation, Kidney
Infectious Disease Medicine
Additional relevant MeSH terms:
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Communicable Diseases
Infections
Disease Attributes
Pathologic Processes