NCT04791098

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

March 8, 2021

Last Update Submit

March 8, 2021

Conditions

Kidney Transplantation

Keywords

Immunization CoverageTransplant RecipientTransplantation, KidneyInfectious Disease Medicine

Outcome Measures

Primary Outcomes (1)

  • Vaccination coverage

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

    Month 6

Secondary Outcomes (2)

  • Infectious complications

    within the 6 months of the transplantation

  • Mortality

    Month 6

Study Arms (2)

Stronger pre-transplant check-up

EXPERIMENTAL

routine patient management + specific infectious diseases consultation

Other: Specific infectious diseases consultation

Standard pre-transplant check-up

NO INTERVENTION

routine patient management + letter sent to nephrologist

Interventions

Specific infectious diseases consultationOTHER

Specific infectious diseases consultation at Clermont Ferrand Hospital with a specialist doctor : * Update vaccinations * Advice to travelers * Diagnostic and treatment of latent tuberculosis infection

Stronger pre-transplant check-up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient over 18
  • On the waiting list for kidney transplantation at Clermont-Ferrand
  • Free and informed consent
  • Affiliation to a social security system

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

Study Officials

  • Olivier Lesens

    CHU de Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+334 73 754 963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 10, 2021

Study Start

September 16, 2020

Primary Completion

March 1, 2022

Study Completion

April 1, 2026

Last Updated

March 10, 2021

Record last verified: 2021-03

Locations

FR(1)