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Not Yet Recruiting NCT07788417

Assessment of Information Provided on Infectious Risk in Solid Organ Transplantation

Conditions: Transplantation Infection, Pulmonary Transplantation

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1000
Sponsor: Fondation Hôpital Saint-Joseph

Location: Groupe Hospitalier Paris Saint-Joseph Paris Groupe Hospitalier Paris Saint-Joseph

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.

Eligibility Criteria

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

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Source: ClinicalTrials.gov (NCT07788417). StuddyBuddy aggregates publicly available trial information.