Activity of Mefloquine Against Urinary Schistosomiasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Reduction of egg excretion
研究概览
简要总结
Urinary schistosomiasis is a debilitating disease in Central Africa and pregnant women are frequently suffering from this condition. Mefloquine is currently investigated as preventive treatment against malaria in pregnancy and mefloquine is also known to exert activity against schistosomiasis. The investigators want to test the hypothesis whether mefloquine may active against urinary schistosomiasis when used as preventive treatment against malaria in pregnancy.
详细描述
Objectives
The principal aim of this clinical trial is to evaluate whether mefloquine - when given as intermittent preventive treatment against malaria in pregnancy - shows in vivo activity against concomitant Schistosoma haematobium infection. This study is therefore a "proof of principle" study and is not intended to establish a clinically satisfying cure rate or to formally compare the efficacy of mefloquine with the standard therapy.
Hypothesis
Two underlying hypotheses have been formulated for this proof of principle study.
Primary hypothesis: Mefloquine reduces egg excretion of Schistosoma haematobium by 50% compared to sulfadoxine/pyrimethamine (S/P) treatment when given as IPTp Secondary hypothesis: Mefloquine may lead to an adequate cure rates of Schistosoma haematobium infections compared to S/P (>80%)
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women after first trimester and before 28th week of pregnancy
- •HIV negative
- •Egg excretion of Schistosoma haematobium (mean >10 eggs per mL urine)
- •Asymptomatic (no signs of complicated Schistosomiasis, no severe anemia)
- •Ability to comply with study protocol
排除标准
- •Intake of anthelminthic or antimalarial drug within 2 months prior to inclusion
- •Allergy to study drugs
研究组 & 干预措施
Mefloquine
15mg/kg mefloquine per dose Women receive two doses: One after the first trimester of pregnancy and the second at least one month after the first dose
干预措施: Mefloquine (Drug)
S/P
sulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations
干预措施: S/P (Drug)
结局指标
主要结局
Reduction of egg excretion
时间窗: 6 weeks after second IPTp
Mefloquine reduces egg excretion of Schistosoma haematobium by 50% compared to sulfadoxine/pyrimethamine (S/P) treatment when given as IPTp
次要结局
- Cure rate(6 weeks after first and second IPTp)
研究者
Michael Ramharter
Ass. Prof. PD
Albert Schweitzer Hospital