Health Benefits of Repeated Treatment in Pediatric Schistosomiasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Change from baseline in schistosome-specific and systemic immune responses
研究概览
简要总结
Objective and Hypotheses: This project has the overall objective of implementing and evaluating new approaches to reducing the current and future burden of urinary schistosomiasis in young children using the antihelminthic drug praziquantel. The investigators hypotheses are that (1) praziquantel treatment will be as effective in children 1 to 5 years of age (who are routinely excluded from schistosomiasis control programmes) as it is in older 6-10 year old children and (2) two treatments will be more effective than a single treatment, especially in children 1 to 5 years of age.
详细描述
This study aims to address the present health inequity by refinement of an existing drug regimen to improve the current and future health of pre-school children and infants. Praziquantel is cheap, highly efficacious and safe, presenting a realistic opportunity of using a pre-existing tool in a modified way to benefit child health and development. The study will focus on children aged 1 to 10 years of age, comparing the impact of single vs. double treatment with PZQ on the current and future health status of the children. The immediate health benefits of PZQ treatment in children aged 6-10 years of age have already been documented and therefore by including 6-10 year olds in the proposed study, we can determine if the effects of PZQ treatment on health and morbidity measures is age dependent. By killing worms PZQ stops the morbidity related to the presence of worms and eggs such as anaemia, abdominal pain, diarrhoea and blood in the urine. Therefore the study will investigate the immediate health benefits of treating pre-school children and infants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •lifelong residents of the area
- •have provided at least 2 urine and 2 stool for parasitological examination
- •have given a blood sample before and after each treatment episode
- •be negative for hookworm, Trichuris and Ascaris
排除标准
- •clinical signs of tuberculosis or malaria
- •presenting with fever
- •have had a recent major operation, illness or vaccination
- •have previously received antihelminthic treatment
结局指标
主要结局
Change from baseline in schistosome-specific and systemic immune responses
时间窗: 6 weeks
Determine the change at 6 weeks post antihelminthic treatment from baseline of schistosome-specific and systemic immune responses
次要结局
- Change from baseline in schistosome-specific and systemic immune responses(12 months)
- Change from baseline in schistosome-related morbidity and disease markers(6 weeks)
- Change from baseline in morbidity and disease markers(12 months)
研究者
Dr Francisca Mutapi
Dr
University of Edinburgh