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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Other: Specific infectious diseases consultation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stronger pre-transplant check-up<br>routine patient management + specific infectious diseases consultation | Other: Specific infectious diseases consultation<br>* Specific infectious diseases consultation at Clermont Ferrand Hospital with a specialist doctor : Update vaccinations Advice to travelers Diagnostic and treatment of latent tuberculosis infection<br>|
| No Intervention: Standard pre-transplant check-up<br>routine patient management + letter sent to nephrologist | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunization Coverage, Transplant Recipient, Transplantation, Kidney, Infectious Disease Medicine