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

University Hospital, Clermont-Ferrand

Status: Enrolling

Conditions: Kidney Transplantation

Treatments: Other: Specific infectious diseases consultation

Study type: Interventional

Funder types: Other

Identifiers

NCT04791098

2019-A02304-53 (Other Identifier)

RBHP 2019 LESENS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Stronger pre-transplant check-up

Experimental group

Description:

routine patient management + specific infectious diseases consultation

Treatment:

Other: Specific infectious diseases consultation

Standard pre-transplant check-up

No Intervention group

Description:

routine patient management + letter sent to nephrologist