Intestinal Schistosomiasis in Children Aged 1-5 Years,Morbidity Assessment and the Effect of Praziquantel on Morbidity; Along Lake Victoria Shorelines.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Presence/absence of organomegaly at Day 0 and 8 months follow-up visits
研究概览
简要总结
This study is about intestinal schistosomiasis, commonly known as bilharzia, in children aged 1-5 years along Lake Victoria shoreline.The children will be screened for S. mansoni and the effects of the disease will be assessed.Children found positive with S. mansoni will be treated with praziquantel and followed up for a year.
详细描述
The study has three phases: in the first phase (Phase I) a baseline pretreatment schistosomiasis morbidity assessment of children aged 1-5 years will take place. The Kato-Katz technique will be used to detect and enumerate S. mansoni eggs in faecal samples from each participating child. Communities with the highest S. mansoni prevalence and intensity will be chosen and included in the study. In the second phase (Phase II) the S. mansoni positive children will be divided randomly into two intervention groups, single and double dose praziquantel treatment arms. Abdominal ultrasound will be combined with clinical examination to accurately identify hepatosplenomegaly. The sizes of both the liver and spleen will be examined. Anthropometric measurements and Hb for each child will also be recorded. In the last phase (Phase III), the effect of praziquantel on S. mansoni morbidity will be evaluated in all the treated children aged 1-5 years.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 5 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •<1-5> years
研究组 & 干预措施
Drug: Praziquantel
Praziquantel 40mg/Kg - single dose
干预措施: Praziquantel (Drug)
Praziquantel
double dose
干预措施: Praziquantel (Drug)
结局指标
主要结局
Presence/absence of organomegaly at Day 0 and 8 months follow-up visits
时间窗: 2 years
次要结局
- Cure rate at 30 days after treatment(2 years)
研究者
Allen Nalugwa
Doctor
Makerere University
