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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)

Primary Purpose

Kidney Transplantation

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Specific infectious diseases consultation
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Transplantation focused on measuring Immunization Coverage, Transplant Recipient, Transplantation, Kidney, Infectious Disease Medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stronger pre-transplant check-up

Standard pre-transplant check-up

Arm Description

routine patient management + specific infectious diseases consultation

routine patient management + letter sent to nephrologist

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Infectious complications
Infectious diseases which require special management (hospitalization, anti-infective treatments)
Mortality
Mortality after kidney transplantation

Full Information

First Posted
March 8, 2021
Last Updated
March 8, 2021
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT04791098
Brief Title
Impact of Infectious Diseases Consultation on Vaccination Coverage Among People Waiting for a Kidney Transplant at the Clermont-Ferrand Hospital
Acronym
PREVAGREF
Official Title
Impact of Infectious Diseases Consultation on Vaccination Coverage Among People Waiting for a Kidney Transplant at the Clermont-Ferrand Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
April 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation
Keywords
Immunization Coverage, Transplant Recipient, Transplantation, Kidney, Infectious Disease Medicine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stronger pre-transplant check-up
Arm Type
Experimental
Arm Description
routine patient management + specific infectious diseases consultation
Arm Title
Standard pre-transplant check-up
Arm Type
No Intervention
Arm Description
routine patient management + letter sent to nephrologist
Intervention Type
Other
Intervention Name(s)
Specific infectious diseases consultation
Intervention Description
Specific infectious diseases consultation at Clermont Ferrand Hospital with a specialist doctor : Update vaccinations Advice to travelers Diagnostic and treatment of latent tuberculosis infection
Primary Outcome Measure Information:
Title
Vaccination coverage
Description
The percentage of fully immunized patients according to the Recommendations of High Council for public Health
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Infectious complications
Description
Infectious diseases which require special management (hospitalization, anti-infective treatments)
Time Frame
within the 6 months of the transplantation
Title
Mortality
Description
Mortality after kidney transplantation
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
+334 73 754 963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Lesens
Organizational Affiliation
CHU de Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise LACLAUTRE
Phone
+33473754963
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Olivier Lesens

12. IPD Sharing Statement

Learn more about this trial

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

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