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

Kidney Transplantation Clinical Trial

— PREVAGREF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04791098
• Other study ID #: RBHP 2019 LESENS
• Secondary ID: 2019-A02304-53
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2020
• Est. completion date: April 2026

Study information

• Verified date: March 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +334 73 754 963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2026
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Kidney Transplantation

Intervention

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

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccination coverage	The percentage of fully immunized patients according to the Recommendations of High Council for public Health	Month 6
Secondary	Infectious complications	Infectious diseases which require special management (hospitalization, anti-infective treatments)	within the 6 months of the transplantation
Secondary	Mortality	Mortality after kidney transplantation	Month 6