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临床试验/NCT01901484
NCT01901484已完成2 期

Intestinal Schistosomiasis in Children Aged 1-5 Years,Morbidity Assessment and the Effect of Praziquantel on Morbidity; Along Lake Victoria Shorelines.

Makerere University1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • <1-5> years

研究组 & 干预措施

Drug: Praziquantel

Active Comparator

Praziquantel 40mg/Kg - single dose

干预措施: Praziquantel (Drug)

Praziquantel

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Allen Nalugwa

Doctor

Makerere University

研究点 (1)

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