A Randomised Comparative Study to Assess the Efficacy and Tolerability of Blood Schizonticidal Treatments With Artesunate Amodiaquine Winthrop® / Coarsucam (ASAQ) Versus Chloroquine (CQ) for Uncomplicated Plasmodium Vivax Monoinfection Malaria
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Assessment of clinical and parasitological efficacy based on temperature and parasitemia after Polymerase chain reaction (PCR) correction
研究概览
简要总结
Primary Objective:
- To demonstrate the non-inferiority of corrected adequate clinical and parasitological response at Day 28 of Artesunate Amodiaquine (ASAQ) versus chloroquine
Secondary Objectives:
-
To assess the non inferiority on the same way as the main criteria:
-
at Day 28 before corrected cure rate
-
at Day 14 and Day 42 before and after corrected cure rate
-
To compare the two groups of treatment in terms of:
-
Efficacy:
-
Proportion of aparasitaemic patients at 24, 48 an 72 hours
-
Proportion of afebrile patients at 24, 48 and 72 hours
-
Percentage of gametocyte carriers during follow-up
-
Evolution of the mean of gametocytes during the 42 days of follow-up
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Evolution of haemoglobin value between Day 0 and Day 7, Day 0 and Day 28
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Clinical and biological tolerability:
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Proportion of any adverse event
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Biological safety: haematology (Red blood cells, Haemoglobin, White Blood Cells, neutrophils, platelets), biochemistry (creatinine, transaminases (alanine amino transferase/ALT), bilirubins)
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ECG (electro encephalogram) (Day 0, Day 3,Day 28) only for patients 10 years old and above
详细描述
Each patient will be followed for a period of 42 days
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 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
artesunate/amodiaquine
artesunate (AS) / amodiaquine (AQ) as fixed dose combination
1 tablet of AS 25mg/ AQ 67,5mg or AS 50mg/AQ 135mg or AS 100mg/ AQ 270mg or 2 tablets of AS 100mg/ AQ 270mg dose according to bodyweight Once daily 3 days of treatment
干预措施: ARTESUNATE + AMODIAQUINE (Drug)
chloroquine
150mg tablets 25mg/kg in 3 days (10mg/kg on day 1 and 7,5 mg/kg on days 2 and 3) dose according to bodyweight Once daily 3 days of treatment
干预措施: Chloroquine (Drug)
结局指标
主要结局
Assessment of clinical and parasitological efficacy based on temperature and parasitemia after Polymerase chain reaction (PCR) correction
时间窗: 28 days
次要结局
- Assessment of clinical and parasitological efficacy based on temperature and parasitemia before and after PCR correction at D14 and D42 and before PCR correction at D28(up to a maximum of 42 days)
- Number of patients without parasite(up to a maximum of 42 days)
- Number of patients without fever(up to a maximum of 42 days)
- Number of patients with gametocytes(up to a maximum of 42 days)
- Change from baseline in Haemoglobin levels(Day 7, Day 28)
- Incidence and severity of adverse events collected(up to a maximum of 42 days)
- ECG (QTc) changes in patients group aged >= 10 years from baseline(Day 3, Day 28)
- Assessment of biological tolerability (bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count) from baseline(up to a maximum of 42 days)