A Proof-of-concept Trial to Evaluate Artesunate-mefloquine as a Novel Alternative Treatment for Schistosomiasis in African Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 726
- 试验地点
- 1
- 主要终点
- Evaluate the efficacy of a single course of artesunate-mefloquine for the treatment of schistosomiasis, compared to the standard PZQ regimen: Parasitological cure rate
研究概览
简要总结
The SchistoSAM study is an open label, two-arm, individually-randomized controlled trial with a non-inferiority design, conducted in northern Senegal.
The study aims at determining if the efficacy of one and of repeated courses of artesunate-mefloquine (AM) is respectively similar to or higher than that of a standard praziquantel (PZQ) treatment. Secondly, the study will assess if novel DNA- and antigen-based diagnostics are more accurate than microscopy in assessing antischistosomal treatment response.
详细描述
The SchistoSAM study is an open label, two-arm, individually-randomized controlled trial with a non-inferiority design, conducted in northern Senegal.
The study aims at determining if the efficacy of one and of repeated courses of artesunate-mefloquine (AM) is respectively similar to or higher than that of a standard praziquantel (PZQ) treatment. Secondly, the study will assess if novel DNA- and antigen-based diagnostics are more accurate than microscopy in assessing antischistosomal treatment response.
For this purpose, 726 school children, aged 6-14 years old and infected with Schistosoma (as demonstrated by presence of eggs in stool and/or urine) will be randomized in one of the following arms:
- AM, available in fixed dose tablets of 25/50 mg and 100/200 mg will be administered once daily for three days in a dose closest to 4 mg/kg artesunate and 8 mg/kg mefloquine. This treatment course will be repeated 2 times at 6-week intervals.
- PZQ, available in tablets of 600 mg, will be administered as a single dose of 40 mg/kg.
Trial participants will be regularly followed-up:
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
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ≥6 and ≤14 years of age
- •Enrolled in one of the selected primary schools in the region
- •Infected with schistosomiasis (i.e. Schistosoma spp. eggs in urine and/or stool)
- •Informed consent from parents/guardians signed
排除标准
- •History of, or ongoing, epilepsy or psychiatric illness (I.e. recent history of depression, generalized anxiety disorder; history of psychosis, schizophrenia or other major psychiatric disorders) or known hypersensitivity to one of the three study drugs
- •Chronic medication for any reason
- •Any severe underlying illness, including severe malnutrition or severe chronic schistosomiasis, based on clinical judgement
- •Any febrile illness
- •Exposure to PZQ or ACT within the three previous months.
研究组 & 干预措施
Praziquantel
Participants in this arm will receive one dose of PZQ at baseline at 40 mg/kg.
干预措施: Praziquantel (Drug)
Artesunate-Mefloquine
Participants in this arm will receive the Artesunate-Mefloquine (fixed-drug)combination at 4 mg/kg artesunate and 8 mg/kg mefloquine at 3 consecutive days. This will be repeated twice; at week 6 and week 12.
干预措施: Artesunate + Mefloquine (Drug)
结局指标
主要结局
Evaluate the efficacy of a single course of artesunate-mefloquine for the treatment of schistosomiasis, compared to the standard PZQ regimen: Parasitological cure rate
时间窗: Week 4
Parasitological cure rate, as assessed by microscopy, after administration of PZQ and after one AM course
Number of safety events of a single course of artesunate-mefloquine for the treatment of schistosomiasis, compared to the standard PZQ regimen
时间窗: Week 4
Pattern of drug-related adverse events and serious adverse events
次要结局
- Monitor the prevalence of Pf molecular markers associated with mefloquine resistance and the potential emergence of reduced artesunate susceptibility(Week 48)
- Evaluate the cumulative efficacy of two additional courses of AM (at 6-week intervals each) for the treatment of schistosomiasis, compared to a single course of AM, and compared to the standard regimen: Cure rate(Week 48)
- Number of safety events of two additional courses of AM (at 6-week intervals each) for the treatment of schistosomiasis, compared to a single course of AM, and compared to the standard regimen.(Week 16)
- Determine the egg reduction rate obtained after single and repeated courses of AM compared to the standard PZQ regimen.(Week 48)
- Determine the parasitological efficacy of single and repeated courses of AM by Schistosoma species and by infection intensity.(Week 16)
- Determine the diagnostic accuracy of novel schistosomiasis antigen- and DNA-based diagnostic assays to monitor antischistosomal treatment response(Week 48)
- Assess the impact of repeated AM courses on schistosomiasis-related morbidity(Week 48)
- Determine the effect of repeated AM courses on prevalence of P. falciparum infection as well as on incidence and morbidity of clinical malaria in school-age children with schistosomiasis(Week 48)