Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST): An Open Label, Randomized Controlled Trial of Single vs. Multiple Treatments of Praziquantel in Intestinal African Schistosomiasis in Côte d'Ivoire
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Cure rate
研究概览
简要总结
An open label, randomized controlled trial of single vs. multiple treatments of praziquantel in intestinal African schistosomiasis in Côte d'Ivoire
This study aims to determine the efficacy of repeated (up to four times) praziquantel treatment against S. mansoni infection in school-age children from Côte d'Ivoire using the traditional Kato-Katz thick smear technique, but also with more accurate and non-invasive antigen- and DNA-detection methods.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a confirmed S. mansoni infection (positive POC-CCA test result and at least one positive out of triplicate Kato-Katz thick smears)
- •Subject is aged between 5 and 18 years and otherwise in good health
- •Subject has received no recent praziquantel treatment in the past month
- •Subject has provided oral assent and provided written informed consent signed by parents/legal guardian
- •Subject is able and willing to provide multiple stool and urine samples during study
排除标准
- •Known allergy to study medication (i.e. praziquantel and albendazole)
- •Pregnancy
- •Lactating
研究组 & 干预措施
Control group (A)
1x praziquantel: Children assigned to group A receive a standard single oral dose of praziquantel (40 mg/kg) at baseline (week 0) and will receive no further treatment until the final visit (week 8).
干预措施: 1x Praziquantel (Drug)
Intervention group (B)
4x praziquantel: Children assigned to group B receive a standard single oral dose of praziquantel (40 mg/kg) at baseline (week 0) and will receive three consecutive praziquantel treatments (40 mg/kg) in the following six weeks with 2 weeks intervals.
干预措施: 4x Praziquantel (Drug)
结局指标
主要结局
Cure rate
时间窗: 8 weeks
The difference in cure rate (percentage negative) between intervention and control arm by Kato-Katz technique
次要结局
- Reduction rates(8 weeks)
- Sensitivity and specificity(8 weeks)
研究者
Meta Roestenberg
MD PhD
Leiden University Medical Center