跳至主要内容
临床试验/NCT07788417
NCT07788417尚未招募不适用

Assessment of Information Provided on Infectious Risk in Solid Organ Transplantation

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2026年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,000
试验地点
1
主要终点
Description of the diversity of recommendations provided by healthcare professionals using questionnaires administered to transplant patients and questionnaires administered to healthcare professional

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Description of the diversity of recommendations provided by healthcare professionals using questionnaires administered to transplant patients and questionnaires administered to healthcare professional

时间窗: single self-administered questionnaire completed at enrolment

Description of the diversity of recommendations provided by healthcare professionals using questionnaires administered to transplant patients and questionnaires administered to healthcare professional

时间窗: single self-administered questionnaire completed at enrolment; one day

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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