Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- P. vivax recurrence
研究概览
简要总结
The study will be an open-labelled randomized clinical trial to determine therapeutic efficacy. Note that this will not be an Investigational New Drug application, as only World Health Organization (WHO)-approved drugs will be used at dosage and for conditions approved.
详细描述
The study will be an open-labelled randomized clinical trial to determine therapeutic efficacy. Note that this will not be an Investigational New Drug application, as only World Health Organization-approved drugs will be used at dosage and for conditions approved.
Eligible patients willing to participate will first be tested prior to enrolment for their glucose-6-phosphate dehydrogenase (G6PD) status by the gold standard spectrophotometric analysis. The investigators will exclude from the study any G6PD deficient (or intermediate females) patient. Treatment allocation will be randomized between i) 7 days of artesunate (2 mg/kg/day for 7 days) alone (Arm1), ii) same artesunate regimen + 0.25 mg/kg/day 14 days of primaquine (Arm2) and iii) same artesunate regimen + 0.5 mg/kg/day 14 days of primaquine (Arm3). All patients will be relocated to a no-transmission city to make sure they are not reinfected during the follow-up. Follow-up will be performed every 24-48h for 90 days. At the end of the follow-up period, all patients that did not receive primaquine (arm1) will be treated according to national guidelines (14 days at 0.25mg/kg/day). Patients will additionally be followed monthly for three months after the end of the relocation.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 15 and older
- •Acute (within 10 days), symptomatic (i.e., history of fever), uncomplicated malaria caused solely by Plasmodium vivax (verified by PCR)
- •G6PD normal (as determined by quantitative spectrophotometric assay)
排除标准
- •Pregnant, planning to become pregnant or lactating women,
- •Received antimalarial drugs in the past month,
- •Hb < 8g/dL, < 1,500 neutrophils/μl, or signs of complicated malaria (e.g., vomiting, convulsions,…),
- •History of primaquine, artesunate or artesunate-mefloquine allergy or intolerance,
- •PCR-positivity for severe acute respiratory syndrome coronavirus 2.
研究组 & 干预措施
Arm2: Primaquine low dose
Enrolled patients will received blood stage antimalarial (artesunate at 2 mg/kg per day every 24h for 7 days) and primaquine at 0.25 mg/kg/day for 14 days (starting at day 7)
干预措施: Primaquine (Drug)
Arm3: Primaquine high dose
Enrolled patients will received blood stage antimalarial (artesunate at 2 mg/kg per day every 24h for 7 days) and primaquine at 0.50 mg/kg/day for 14 days (starting at day 7)
干预措施: Primaquine (Drug)
Arm2: Primaquine low dose
Enrolled patients will received blood stage antimalarial (artesunate at 2 mg/kg per day every 24h for 7 days) and primaquine at 0.25 mg/kg/day for 14 days (starting at day 7)
干预措施: Artesunate (Drug)
Arm1: No primaquine
Enrolled patients will only received blood stage antimalarial (artesunate at 2 mg/kg per day every 24h for 7 days)
干预措施: Artesunate (Drug)
Arm3: Primaquine high dose
Enrolled patients will received blood stage antimalarial (artesunate at 2 mg/kg per day every 24h for 7 days) and primaquine at 0.50 mg/kg/day for 14 days (starting at day 7)
干预措施: Artesunate (Drug)
结局指标
主要结局
P. vivax recurrence
时间窗: 3 months
Proportion of patients experiencing recurrence as measured by microscopy and PCR and time to recurrence
Markers of P. vivax recurrences
时间窗: 3 months
Gene expression or serological markers associated with P. vivax recurrence
次要结局
- Genotypes of relapsing P. vivax parasites(3 months)
研究者
David Serre
Professor
University of Maryland, Baltimore