Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07788417

Assessment of Information Provided on Infectious Risk in Solid Organ Transplantation

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Paris Saint-Joseph, Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Benoît PILMIS;, MD

CONTACT

[email protected]

01.44.12.78.20

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Acronym: ENVIR-TRANS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 26, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.