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临床试验/NCT05417815
NCT05417815已完成不适用

Interest of Nitazoxanide Treatment of Enterocytozoon Bieneusi Intestinal Microsporidiosis

University Hospital, Clermont-Ferrand24 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2022年4月1日最近更新:
适应症

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

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

研究者

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

研究点 (24)

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