A Randomized, Double Blind, Placebo-controlled Clinical Trial of Monthly DHA-piperaquine for Malaria Prevention in Cambodia.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- Protective efficacy
研究概览
简要总结
Trial of monthly DHA-piperaquine for malaria prevention in health volunteers.
详细描述
This is a two arm, randomized, double-blind, placebo controlled cohort study to determine the protective efficacy of a monthly 2 day treatment course of Dihydroartemisinin-Piperaquine (DP) in adult volunteers in malaria endemic areas of Cambodia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Volunteer 18-65 years of age
- •Able to give informed consent
- •Likely to reside in malaria 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
- •Agrees not to seek outside medical care for febrile illness, except in emergency situations, unless referred by study team
- •Authorized by local commander to participate in the study if on active duty
排除标准
- •Known allergy or other contraindication to DHA, piperaquine treatment, and/or primaquine treatment
- •Significant acute comorbidity requiring urgent medical intervention
- •Positive malaria blood smear.
- •Treatment with an antimalarial drug in the past 30 days.
- •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
- •Significantly abnormal EKG including a QTcF interval greater than 450ms at baseline (or 470ms for females) using Fridericia's correction
- •Regular current use of known QTc prolonging medications
- •History of sudden cardiac death in an immediate family member, or personal history of known symptomatic coronary artery disease or arrhythmias
- •Judged by the investigator to be otherwise unsuitable for study participation or non-compliant with study requirements
研究组 & 干预措施
DHA-piperaquine
DHA-piperaquine monthly 2 day treatment course
干预措施: DHA-piperaquine (Drug)
Placebo
Matching placebo control
干预措施: placebo (Drug)
结局指标
主要结局
Protective efficacy
时间窗: 4 months
To quantify protective efficacy for the prevention of malaria infection in a setting of mixed multidrug resistant P. falciparum and P. vivax malaria, particularly in non-immune volunteers, in two treatment groups - monthly DHA-piperaquine vs. placebo. Protective efficacy will be defined by reduction in the incidence of malaria between treatment and placebo groups.
次要结局
- Cardiac safety of piperaquine as determined by QT interval prolongation(4-5 months)
研究者
Philip Smith
Chief, Department of Immunology and Medicine
Armed Forces Research Institute of Medical Sciences, Thailand