Assessment of Information Provided on Infectious Risk in Solid Organ Transplantation (ENVIR-TRANS)

August 26, 2026 updated by: Fondation Hôpital Saint-Joseph

Solid organ transplantation (lung, kidney, liver, and heart) is a major therapeutic option for many end-stage chronic diseases. In France, several hundred patients undergo transplantation each year, supported by advances in surgery, immunosuppression, and care organization (e.g., 308 lung transplants in 2023, +2.5%).

This trend includes broader indications, greater use of "marginal" donors, and an ageing recipient population (mean age of lung transplant recipients: 53 years in 2022). Infections remain a leading cause of post-transplant morbidity and mortality: up to 19.2% of early deaths and the main cause of death in the first year. Incidence is especially high after lung transplantation, and the infection risk persists lifelong.

Patients receive education on high-risk exposures (food, travel, social contacts, animals, leisure), yet no standardized international guidelines exist. In France, counseling varies widely between centers and is often based on limited evidence. Patient adherence is poorly documented and sometimes low (≈18% for dietary advice).

No French data currently describe the actual recommendations given, how patients apply them, or their impact on quality of life. We therefore propose a multicenter cross-sectional study in lung (and heart-lung) transplant recipients to describe the recommendations provided, assess their concordance with patient behaviors, and identify discrepancies. Findings may help harmonize recommendations while accounting for the specificities of lung transplantation. The study will later be extended to kidney, liver, and heart transplant recipients.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Benoît PILMIS;, MD
Phone Number: 01.44.12.78.20
Email: bpilmis@ghpsj.fr

Study Locations

France
- - Bordeaux, France
    - Hôpital Haut-Lévêque-Pessac, Bordeaux
  - Lyon, France
    - Hôpital Louis Pradel - Lyon
    - Principal Investigator:
      
      Claire Merveilleux Du Vignaux, MD
  - Marseille, France
    - Hôpital Nord - Marseille
  - Nantes, France
    - Hôpital Nord Saint-Herblain- Nantes
    - Principal Investigator:
      
      Adrien TISSOT, MD
  - Paris, France
    - Hôpital Bichat
    - Principal Investigator:
      
      Gaëlle WEISENBURGER, MD
  - Strasbourg, France
    - CHRU Strasbourg
    - Principal Investigator:
      
      Benjamin RENAUD-PICARD, MD
  - Suresnes, France
    - Hôpital Foch
- Groupe Hospitalier Paris Saint-Joseph
  - Paris, Groupe Hospitalier Paris Saint-Joseph, France, 75014
    - Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Adult patients who have received a lung transplant or a heart-lung transplant.

Description

Inclusion Criteria:

Patient aged 18 years or older at the time of transplantation
French-speaking patient
Patient who has undergone a lung transplantation or a heart-lung transplantation

Exclusion Criteria:

Patients under legal guardianship or curatorship
Patients deprived of their liberty
Patients subject to a judicial protection measure (safeguard of justice)
Patients who object to the use of their data for the purposes of this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Description of the diversity of recommendations provided by healthcare professionals using questionnaires administered to transplant patients and questionnaires administered to healthcare professional Time Frame: single self-administered questionnaire completed at enrolment; one day	single self-administered questionnaire completed at enrolment; one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Hôpital Saint-Joseph

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

March 15, 2028

Study Completion (Estimated)

March 15, 2028

Study Registration Dates

First Submitted

August 4, 2026

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 26, 2026

Study Record Updates

Last Update Posted (Actual)

August 31, 2026

Last Update Submitted That Met QC Criteria