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临床试验/NCT02162875
NCT02162875已完成不适用

Parasitologic Impact of Different Mass Drug Administration Strategies Against Schistosoma Mansoni in Endemic Areas of Mwanza Region, Tanzania, Where Prevalence is 25% or Above

DBL -Institute for Health Research and Development1 个研究点 分布在 1 个国家目标入组 37,500 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37,500
试验地点
1
主要终点
Effect of Mass drug administration on prevalence and intensity of Schistosoma mansoni among children and adults

研究概览

简要总结

The objective of this study is to determine the strategy for mass drug administration (MDA) which provides the greatest reductions in prevalence and intensity of Schistosoma mansoni in school-aged children after 4 years of intervention.

详细描述

Intestinal schistosomiasis is caused by the blood-dwelling flatworm Schistosoma mansoni. Despite the increasing focus on the use of praziquantel against schistosomiasis infections for the last three decades many areas in Sub-Saharan Africa still have high prevalences and intensities of schistosomiasis especially among school-age children. This is true for the area of Mwanza Region of Tanzania adjacent to Lake Victoria. The study is a six arm study and includes 150 communities (25 in each arm). From each community 100 school children (aged 9-12 years), 100 first year students (aged 7-8 years) and 50 adults (aged 20-55 years) are included, diagnosed and treated with praziquantel using strategies composing of a mixture of community wide treatment (CWT), school-based treatment (SBT) and years without treatment (-T). The 100 school children provided stool specimens on three consecutive days, while the 100 first year students and 50 adults with few exceptions only provided one specimen. The treatment strategies during the 4 years for the different arms are as follows: Arm 1: CWT, CWT, CWT, CWT; Arm 2: CWT, CWT, SBT, SBT; Arm 3: CWT, CWT -T, -T; Arm 4: SBT, SBT, SBT, SBT; Arm 5: SBT, SBT, -T, -T; Arm 6: SBT, -T, SBT, -T.

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
None

入排标准

年龄范围
7 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All school children and adults who consent to participate can be included

排除标准

  • Those not consenting or with any chronic disease not related to schistosomiasis will be excluded

研究组 & 干预措施

MDA once a year

Experimental

Community wide treatment (CWT) once a year for four years with single dose praziquantel 40mg/kg

干预措施: Praziquantel (Drug)

MDA 2nd year CWT follwed by 2 years SBT

Experimental

Treatment with praziquantel as arm 1 given by two years of community wide treatment (CWT) followed by two years of school-based treatment (SBT)

干预措施: Praziquantel (Drug)

Praziquantel every second year CWT

Experimental

Treatment with praziquantel given every second year as CWT

干预措施: Praziquantel (Drug)

MDA once a year SBT

Experimental

Treatment with praziquantel as above given as 4 years of SBT

干预措施: Praziquantel (Drug)

MDA given for 2 years as SBT

Experimental

Treatment with praziquantel as above given for 2 years as SBT followed by 2 years without MDA

干预措施: Praziquantel (Drug)

MDA as SBT 1year and 1 year without MDA

Experimental

Treatment with praziquantel given as one years of SBT alternating with one year without treatment

干预措施: Praziquantel (Drug)

结局指标

主要结局

Effect of Mass drug administration on prevalence and intensity of Schistosoma mansoni among children and adults

时间窗: May -October 2016 (5 months)

Prevalence and intensity of Schistosoma mansoni

次要结局

  • Mass drug administration coverage(May -October 2016 (5 months))

研究者

发起方
DBL -Institute for Health Research and Development
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pascal Magnussen

Associate Professor

DBL -Institute for Health Research and Development

研究点 (1)

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