Interest of Nitazoxanide Treatment of Enterocytozoon Bieneusi Intestinal Microsporidiosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 24
- 主要终点
- efficiency by symptoms
研究概览
简要总结
Microsporidia are pathogenic fungi mainly responsible for profuse watery diarrhea, requiring management in immunocompromised patients. The main immunocompromised population affected by these infections consists of solid organ transplant recipients (SOT), mainly kidney (~70% of cases in immunocompromised patients). In this population, the infection is severe, and becomes chronic in the absence of appropriate care, the species Enterocytozoon bieneusi being found in more than 95% of these cases. Reducing immunosuppression (adjustment of immunosuppressive therapy) can sometimes be enough to eliminate the pathogen. However, in some cases, specific treatment is necessary. The only molecule whose efficacy has been proven to date to treat infections caused by E. bieneusi is fumagillin (FLISINT®), however its production has been stopped for almost 2 years. Due to the therapeutic impasse, the use of nitazoxanide (ALINIA®) to treat E. bieneusi microsporidiosis is becoming common, despite the lack of proof of its efficacy. It seems important and urgent to evaluate the relevance of the use of nitazoxanide, particularly in SOT, for the treatment of intestinal microsporidiosis due to E. bieneusi.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With a diagnosis of intestinal infection caused by E. bieneusi between 01/01/2018 and 03/31/2022
- •having received treatment with nitazoxanide ("NITAZO" group), or fumagillin ("FUMA" group), or albendazole ("ABZ") or having received no specific treatment but having benefited from an adjustment of the doses of immunosuppressants ("IS" group)
排除标准
- •With a diagnosis of extraintestinal infection
- •With a diagnosis of infection by a species other than E. bieneusi
结局指标
主要结局
efficiency by symptoms
时间窗: 1 year
time to resolution of symptoms
tolerance of treatment
时间窗: 1 year
duration of treatment
efficiency by parasitology
时间窗: 1 year
parasitological negativation
efficiency by relapses
时间窗: 1 year
number of relapses
tolerance with side effects
时间窗: 1 year
side effects during treatment: value of platelets, liver enzymes, occurrence of drug interactions
次要结局
未报告次要终点
