Childhood Schistosomiasis: a Novel Strategy Extending the Benefits/Reach of Antihelminthic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Re-infection rates in children treated upon first infection compared to re-infection rates in children treated within 12 months of infection.
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 project aims to (1) determine the operational health benefits of treating schistosome infections early on re-infection and morbidity reduction, (2) determine if gut or urine microbiome structure (species diversity or abundance) is a risk factor for S. haematobium infection or morbidity, and (3) elucidate the factors and underlying mechanisms mediating the reduction/reversal of schistosome-related morbidity and resistance against infection/re-infection in young children.
详细描述
This study aims to refine current paediatric treatment of schistosomiasis using the drug Praziquantel (PZQ) 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 3 to 5 years of age, comparing the impact of early vs. later treatment with PZQ on the current and future health status of the children. 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 as well as induced immune responses associated with reduced re-infection rates. Therefore the study will investigate the immediate health benefits of treating pre-school children and infants and the effects of treatment on re-infection rates.
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
- 3 Years 至 5 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 schistosomes, hookworm, Trichuris and Ascaris
- •have frequent contact with infective water
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
- •are infected with any helminths
结局指标
主要结局
Re-infection rates in children treated upon first infection compared to re-infection rates in children treated within 12 months of infection.
时间窗: 12 months
Compare re-infection rates in children treated upon first infection vs. those treated within 12 months of infection.
次要结局
- Determine the treatment-related changes in systemic (cytokine levels) and schistosome- specific ( antibody levels) immune responses in children treated upon first infection vs. those treated within 12 months of infection.(12 months)
- Change in immune measures (cytokine and antibody levels) following curative treatment(24 months from baseline)
- Compare the change in the gut and urine microbiome structure from baseline in children who become infected and compare to children who remain uninfected.(12 months)
- Reduction of morbidity (UACR and haematuria levels) levels in children treated upon first infection compared to morbidity reduction in children treated within 12 months of infection.(12 Months)