Assessment of Information Provided on Infectious Risk in Solid Organ Transplantation (ENVIR-TRANS)
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.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Benoît PILMIS;, MD
- 电话号码:01.44.12.78.20
- 邮箱:bpilmis@ghpsj.fr
学习地点
-
-
-
Bordeaux、法国
- Hôpital Haut-Lévêque-Pessac, Bordeaux
-
Lyon、法国
- Hôpital Louis Pradel - Lyon
-
首席研究员:
- Claire Merveilleux Du Vignaux, MD
-
Marseille、法国
- Hôpital Nord - Marseille
-
Nantes、法国
- Hôpital Nord Saint-Herblain- Nantes
-
首席研究员:
- Adrien TISSOT, MD
-
Paris、法国
- Hôpital Bichat
-
首席研究员:
- Gaëlle WEISENBURGER, MD
-
Strasbourg、法国
- CHRU Strasbourg
-
首席研究员:
- Benjamin RENAUD-PICARD, MD
-
Suresnes、法国
- Hôpital Foch
-
-
Groupe Hospitalier Paris Saint-Joseph
-
Paris、Groupe Hospitalier Paris Saint-Joseph、法国、75014
- Groupe Hospitalier Paris Saint-Joseph
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Description of the diversity of recommendations provided by healthcare professionals using questionnaires administered to transplant patients and questionnaires administered to healthcare professional
大体时间:single self-administered questionnaire completed at enrolment; one day
|
single self-administered questionnaire completed at enrolment; one day
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2026-A00507-44
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.