An Active Malaria Epidemiology Cohort Study With Evaluation of a 2 Day Versus 3 Day Treatment Regimen of Dihydroartemisinin (DHA)-Piperaquine for Patients With Uncomplicated Malaria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Adequate clinical and parasitological response to a treatment regimen of DHA-PIP for Plasmodium falciparum
研究概览
简要总结
An observational cohort and malaria treatment study in Cambodia.
详细描述
This is an active observational Cohort Study of malaria epidemiology with a nested two arm, randomized, open label Treatment Study comparing the efficacy, safety, tolerability and pharmacokinetics of a two versus three day course of Dihydroartemisinin-Piperaquine (DP) for those developing uncomplicated malaria. At the conclusion of the Cohort Study, a subset of volunteers with documented exposure to Plasmodium vivax during the study will be treated with primaquine as presumptive anti-relapse therapy directed against the exoerythrocytic malaria stages of P. vivax, and followed passively for an additional 6 months.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Otherwise healthy volunteer, 18-65 years of age, eligible for care at an RCAF facility, and at risk for contracting malaria
- •Able to provide informed consent
- •Likely to reside in endemic area for the duration of the study
- •Available for follow-up for anticipated study duration, and agrees to participate for the duration of the study
- •Authorized by local commander to participate in the study if on active duty
排除标准
- •History of allergic reaction or contraindication to DHA or piperaquine
- •Significant acute comorbidity requiring urgent medical intervention
- •Pregnant or lactating female, or a female of childbearing age who does not agree to use a highly effective method of birth control during the study
- •Clinically significant abnormal EKG, including a QTc interval > 500 ms.
- •Judged by the investigator to be otherwise unsuitable for study participation
研究组 & 干预措施
3 day therapy
Total dose split over 3 days (3 tablets per day)
干预措施: Dihydroartemisinin piperaquine (Drug)
2 day therapy
Total dose split over 2 days (4.5 tablets per day)
干预措施: Dihydroartemisinin piperaquine (Drug)
结局指标
主要结局
Adequate clinical and parasitological response to a treatment regimen of DHA-PIP for Plasmodium falciparum
时间窗: 6 months
Number of malaria recurrences for 2 and 3 day DHA-PIP drug regimens within 42 days after treatment of malaria infection, diagnosed by positive PCR-corrected malaria microscopy.
次要结局
- Number of Cambodian study subjects with reduced or null activity hepatic cytochrome P450 2D6 alleles(1 year)
- Number of subjects with reduced or null hepatic CYP2D6 enzyme phenotype using activity-score A system(1 year)