Intestinal Microsporidiosis in French Heart Transplant Recipients
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
- 否
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
