Kidney TransplantationPREVAGREFNCT04791098
Impact of Infectious Diseases Consultation on Vaccination Coverage Among People Waiting for a Kidney Transplant at the Clermont-Ferrand Hospital
A study testing Specific infectious diseases consultation in people with Kidney Transplantation, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Specific infectious diseases consultation
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2020to Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18
- On the waiting list for kidney transplantation at Clermont-Ferrand
- Free and informed consent
- Affiliation to a social security system
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise LACLAUTRE, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Olivier Lesens
About this study
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.
Read the detailed 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.
- Conditions
- Kidney Transplantation
- Being tested
- Specific infectious diseases consultation
- Keywords
- Immunization Coverage, Transplant Recipient, Transplantation, Kidney, Infectious Disease Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Stronger pre-transplant check-up | Experimental | routine patient management + specific infectious diseases consultation Receives: Other: Specific infectious diseases consultation |
| Standard pre-transplant check-up | No intervention | routine patient management + letter sent to nephrologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccination coverage
The percentage of fully immunized patients according to the Recommendations of High Council for public Health
Measured: Month 6
Secondary outcomes (2)
Infectious complications
Infectious diseases which require special management (hospitalization, anti-infective treatments)
Measured: within the 6 months of the transplantation
Mortality
Mortality after kidney transplantation
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start16 Sep 2020
- Primary completionMar 2022 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Lesens, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791098
- Sponsor's protocol ID
- RBHP 2019 LESENS
- Other IDs
- 2019-A02304-53
- Acronym
- PREVAGREF
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Infectious Diseases Consultation on Vaccination Coverage Among People Waiting for a Kidney Transplant at the Clermont-Ferrand Hospital
- ClinicalTrials.gov ID
- NCT04791098
- Acronym / sponsor ID
- PREVAGREF / RBHP 2019 LESENS
- Conditions
- Kidney Transplantation
- Keywords
- Immunization Coverage, Transplant Recipient, Transplantation, Kidney, Infectious Disease Medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stronger pre-transplant check-up | Experimental | Other: Specific infectious diseases consultationroutine patient management + specific infectious diseases consultation |
| Standard pre-transplant check-up | No intervention | –routine patient management + letter sent to nephrologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient over 18
- On the waiting list for kidney transplantation at Clermont-Ferrand
- Free and informed consent
- Affiliation to a social security system
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific infectious diseases consultationSpecific infectious diseases consultation at Clermont Ferrand Hospital with a specialist doctor : * Update vaccinations * Advice to travelers * Diagnostic and treatment of latent tuberculosis infection | Other | Stronger pre-transplant check-up |
Primary outcome
Vaccination coverage
Time frame: Month 6
The percentage of fully immunized patients according to the Recommendations of High Council for public Health
2 secondary outcomes
Infectious complications
Time frame: within the 6 months of the transplantation
Mortality
Time frame: Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Lesens principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific infectious diseases consultation in people with Kidney Transplantation, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+334 73 754 963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccination coverage (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.