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

NCT ID: NCT04791098

Last Updated: 2021-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-16

Study Completion Date

2026-04-30

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.

Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Stronger pre-transplant check-up

routine patient management + specific infectious diseases consultation

Group Type EXPERIMENTAL

Specific infectious diseases consultation

Intervention Type OTHER

Specific infectious diseases consultation at Clermont Ferrand Hospital with a specialist doctor :

* Update vaccinations
* Advice to travelers
* Diagnostic and treatment of latent tuberculosis infection

Standard pre-transplant check-up

routine patient management + letter sent to nephrologist

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier Lesens

Role: PRINCIPAL_INVESTIGATOR

CHU de Clermont-Ferrand

Locations

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CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lise LACLAUTRE

Role: CONTACT

+334 73 754 963

Facility Contacts

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Lise LACLAUTRE

Role: primary

+33473754963

Other Identifiers

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2019-A02304-53

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2019 LESENS

Identifier Type: -

Identifier Source: org_study_id

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