2024-515968-32-00招募中2 期
Randomized non-inferiority clinical trial to evaluate the efficacy of a single fixed dose of 18 mg ivermectin for the treatment of uncomplicated strongyloidiasis.
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca7 个研究点 分布在 1 个国家目标入组 276 人开始时间: 2024年7月22日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 276
- 试验地点
- 7
- 主要终点
- Proportion of patients with microbiological cure at 6 months of treatment.
研究概览
简要总结
To assess the efficacy in terms of microbiological cure and safety of 18 mg single fixed dose ivermectin for the treatment of uncomplicated strongyloidiasis in immunocompetent adults compared to weight-adjusted single dose ivermectin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Ensayo clínico de no inferioridad fase IIb aleatorizado, controlado, abierto y multicéntrico
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age equal to or greater than 18 years.
- •Signature of the informed consent.
- •Diagnosis of strongyloidiasis either by direct parasitological methods (detection of larvae in coproparasitology or in the specific Strongyloides culture) or by positivity of a serological technique (ELISA) with an optical density index (OD) greater than or equal to
- •Current residence in an area with no evidence of active transmission of strongyloidiasis.
排除标准
- •Pregnancy or lactation
- •Intolerance or allergy to ivermectin.
- •Presence of any condition that implies immunosuppression (both due to drugs and underlying disease): treatment with corticosteroids at a dose greater than or equal to 20 mg/day for more than 14 days, treatment with cytotoxic or antimetabolites, bone marrow transplantation or Solid organ failure, biologic drugs, active solid or hematologic neoplasm, hypogammaglobulinemia, HIV infection with a CD4 count less than 200 cells/mm
- •Kidney failure (glomerular filtration rate equal to or less than 30 ml/min) or advanced liver disease (Child B or C).
- •Loa loa co-infection (due to risk of encephalopathy when administering ivermectin).
- •Complicated strongyloidiasis: Hyperinfestation syndrome due to Strongyloides (disease limited to the lungs and intestinal tract, but with severe symptoms due to the high number of larvae) or disseminated strongyloidiasis (larvae found in organs outside the lungs and intestinal tract).
- •Planned travel to an area with evidence of active strongyloidiasis transmission in the next 6 months (to prevent possible reinfections).
- •Previous treatment with ivermectin (in the last year from the inclusion date).
结局指标
主要结局
Proportion of patients with microbiological cure at 6 months of treatment.
Proportion of patients with microbiological cure at 6 months of treatment.
次要结局
未报告次要终点
研究者
Fernando Salvador
Scientific
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
研究点 (7)
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