ISRCTN06498763已完成不适用
Mefloquine, artesunate and mefloquine-artesunate in the treatment of Schistosoma mansoni and Schistosoma haematobium infections in Côte d?Ivoire
Swiss Tropical Institute (Switzerland)0 个研究点目标入组 120 人开始时间: 2008年10月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Schoolchild (aged 8 - 16 years, either sex) infected with S. mansoni (study 1) or S. haematobium (study 2), as assessed by the presence of egg(s) in the stool (S. mansoni) or urine (S. haematobium)
- •2. Weight of schoolchild greater than 25 kg
- •3. Able and willing to be examined by a physician at the beginning of the study and at the end of study (3 weeks post-treatment)
- •4. Able and willing to provide multiple stool or urine samples at the beginning and end of study
- •5. Absence of major systemic illnesses, as assessed by the medical doctor, upon initial clinical assessment
- •6. Absence of psychiatric disorders and epilepsy
- •7. No known or reported hypersensitivity to mefloquine and/or artesunate
- •8. No known or reported history of chronical illness as cancer, diabetes, chronic heart, liver or renal disease
- •9. Signed written informed consent sheet by parents/legual guardians and child
- •10. For females aged 12 years and above, not pregnant in the first trimester, as assessed by a female nurse (interview and pregnancy test if need be), upon initial clinical assessment
排除标准
- •1. Schoolchild who has clinical malaria (i.e. axillary temperature greater than or equal to 37.5°C and parasitaemia, as assessed by thick and thin blood film examination)
- •2. Pregnancy first trimester
- •3. Presence of any abnormal medical condition, judged by the study physician
- •4. History of acute or severe chronic disease, including hepato-splenic schistosomiasis, macrohaematuria and bloody stools
- •5. Psychiatric disorders and epilepsy
- •6. Use of artesunate, artemether, any artemisinin-based combination therapy, mefloquine or praziquantel within the past 7 days
- •7. Attending other clinical trials during the study
研究者
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