NCT00755560进行中（未招募）3 期
Treatment of Asymptomatic Toxocariasis With Albendazole in Children. A Prospective, Randomized, Placebo-controlled Clinical Trial
Hospital de Niños R. Gutierrez de Buenos Aires1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Mean absolute reduction in eosinophil count from baseline
研究概览
简要总结
The purpose of this study is to evaluate effectiveness of albendazole in the treatment of the asymptomatic infection with the parasite Toxocara in children. Treatment response is defined as a reduction in the number of eosinophils in blood. The study drug will be compared to placebo and randomly assigned in a double blind manner. Follow up will be prospective. 50 children (25 per group) will be enrolled in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric ambulatory patients with asymptomatic toxocariasis
- •Children 2 - 15 years old
- •Absolute eosinophil count > 1100 / mm3
- •Normal ophthalmoscopy
排除标准
- •Treatment with a benzimidazole in the previous year
- •Infection by other nematodes (Ascaris lumbricoides, strongyloides stercoralis, uncinarias, Trichuris trichuria)
- •Symptomatic patients (prolonged fever, acute pneumonitis, hepatomegaly, splenomegaly, ocular compromise due to toxocara)
- •Concomitant diseases
- •Immunocompromised patients
- •Altered liver or kidney function
- •Pregnancy
研究组 & 干预措施
Albendazole
Active Comparator
Albendazole 10 - 15 mg/kg/day BID for 15 days
干预措施: Albendazole (Drug)
Placebo
Placebo Comparator
Placebo BID for 15 days
干预措施: Placebo (Drug)
结局指标
主要结局
Mean absolute reduction in eosinophil count from baseline
时间窗: 12 months after treatment
次要结局
- Reduction in eosinophil count in more than 60% from baseline(1 year)
- Mean absolute reduction in eosinophil count(3, 6, 9 months after treatment)
- Incidence of adverse drug events(3, 6, 9 and 12 months after treatment)
研究者
Dr Jaime Altcheh
Service Head, Parasitology and Chagas Service
Hospital de Niños R. Gutierrez de Buenos Aires
研究点 (1)
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