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Assessment of Information Provided on Infectious Risk in Solid Organ Transplantation

Assessment of Information Provided on Infectious Risk in Solid Organ Transplantation

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07788417
Acronym
ENVIR-TRANS
Enrollment
1000
Registered
2026-08-26
Start date
2026-09-15
Completion date
2028-03-15
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Transplantation, Transplantation Infection

Brief summary

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.

Interventions

None listed

Sponsors

Fondation Hôpital Saint-Joseph
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Description of the diversity of recommendations provided by healthcare professionals using questionnaires administered to transplant patients and questionnaires administered to healthcare professionalsingle self-administered questionnaire completed at enrolment; one day

Countries

France

Contacts

CONTACTBenoît PILMIS;, MD
bpilmis@ghpsj.fr01.44.12.78.20

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026