Evaluation of the Effect of Artemisinin-based Combination Therapies on Urinary Schistosoma Haematobium When Administered for the Treatment of Malaria Co-infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Egg Reduction Rate (ERR)
研究概览
简要总结
Open labelled, non randomized study to evaluate the effects of Artemisinin based Combined Therapies(ACTs) on schistosomiasis since Praziquantel (PZQ) which is presently the drug of choice for treating Schistosomiasis (STS), is ineffective on immature stages and there is known parasite resistance. ACTs when combined with PZQ, targeting different stages of the life cycle has shown some effectivity.
详细描述
Study population included all subjects in study area who signed a written Informed Consent Form diagnosed with Malaria- STS co-infection. Those excluded were treated with PZQ prior 6 weeks, have drug intolerance or pregnant. At Inclusion, Basic Demographic data was recorded and urine samples analysed. During the follow up visits, urine samples were collected on D28 and D42 (6 weeks post treatment). Post treatment assessment was done on urine samples collected on at least two consecutive days and at the end of follow up, all subjects were treated with a single dose pf PZQ (40 mg/kg) as recommended by WHO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Malaria infection diagnosed by Rapid Diagnostic Tests (RDTs) or thick blood smear
- •Urinary schistosomiasis diagnosed by presence of Schistosoma haematobium eggs in the urine before malaria treatment
- •Written informed consent
排除标准
- •Patients treated with PZQ during the previous 6 weeks
- •Known intolerance /allergy to any study drug
- •Pregnancy
研究组 & 干预措施
artemisinin-based combination therapies
subjects given Artemisinin-based combined therapies according to the study instruction
干预措施: Artesunate-Pyronaridine (Drug)
artemisinin-based combination therapies
subjects given Artemisinin-based combined therapies according to the study instruction
干预措施: Artemether-Lumefantrine (Drug)
non-artemisinin drugs
subjects given non artemisinin based combined therapies like describe in the study protocol
干预措施: Artefenomel-Ferroquine (Drug)
结局指标
主要结局
Egg Reduction Rate (ERR)
时间窗: Day 42
Evaluate ERR conferred by ACTs as treatment of infection with Schistosoma hematobia
次要结局
- Cure Rate (CR)(Day 42)