跳至主要内容
临床试验/NCT06986980
NCT06986980招募中不适用

Intestinal Microsporidiosis in French Heart Transplant Recipients

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2025年5月5日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
39
试验地点
1
主要终点
Dosage of immunosuppressants at diagnosis

研究概览

简要总结

The investigators propose to carry out a national retrospective study to collect epidemiological, biological, clinical and therapeutic data on microsporidiosis among heart transplant patients.

详细描述

Microsporidia constitute a large family of intracellular eukaryotes infecting a wide range of hosts, ranging from insects to mammals and birds. Within this group, some species are responsible for intestinal syndromes manifested by abundant watery diarrhea, which can be particularly severe in immunocompromised individuals. In the 1980s, HIV-positive patients at the AIDS stage represented the primary population at risk. Nowadays, the most frequently affected patients among immunocompromised individuals are solid organ transplant recipients, for whom the management of this infection can be challenging. A neglected pathology until a few years ago, epidemiological data describing intestinal microsporidiosis in solid organ transplant recipients are scarce. The invesigators previously published the first data in kidney and liver transplant recipients. Here the investigators propose to carry out a national retrospective study to collect epidemiological, biological, clinical and therapeutic data on heart transplant patients.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • heart transplant patients diagnosed with intestinal microsporidiosis
  • diagnosis made before December 31, 2024 in France (metropolitan France and overseas territories)

排除标准

  • patient opposition

结局指标

主要结局

Dosage of immunosuppressants at diagnosis

时间窗: 1 year

Demographic data: age

时间窗: 1 year

expressed in years old

Demographic data: sex

时间窗: 1 year

choice between: male/female

Time between transplant and microsporidiosis

时间窗: 1 year

expressed in days, or years if \>365 days

At diagnosis: number of days since the onset of symptoms

时间窗: 1 year

expressed in number of days

Weight loss at diagnosis

时间窗: 1 year

expressed in kilogram or in percent (compared to usual weight of the patient)

Time to stool negativation

时间窗: 1 year

expressed in number of days between onset of treatment and first negative PCR during follow-up

Creatinine level in blood at Day 0 (diagnosis) and Month 3

时间窗: 3 months

expressed in µM

Numeration of cells in blood: platelets, lymphocytes, neutrophils at Day 0 (diagnosis) and Month 3

时间窗: 3 months

expressed in Giga per litre

Gammaglobulins in blood at diagnosis

时间窗: 1 year

expressed in gram per litre

次要结局

未报告次要终点

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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