A Nested Open Labeled Study to Compare the Effectiveness and Safety of a Fixed-dose Combination of Artesunate Plus Amodiaquine (ASAQ Winthrop®) in the Unsupervised Treatment of Uncomplicated Plasmodium Falciparum Malaria Attacks in Two Patient Groups Enrolled at Two Year-intervals in a Pilot District of Côte d'Ivoire
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 580
- 试验地点
- 1
- 主要终点
- Polymerase chain reaction (PCR)-corrected and uncorrected clinical and parasitological cure rate (ACPR)
研究概览
简要总结
The primary objective of this study is to demonstrate the non-inferiority of Polymerase Chain Reaction (PCR)-adjusted adequate clinical and parasitological response to artesunate plus amodiaquine at Day 28 in two groups of patients treated at the beginning of an artesunate plus amodiaquine implementation program and 24 months later.
The secondary objectives are Clinical and biological tolerability Evolution of gametocyte carriage Proportion of patients without fever at Day 3 Proportion of patients without parasite at Day 3 Treatment compliance Impact of implementation on anemia Measure of parasite sensibility to amodiaquine
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Body weight >=5kg
- •Plasmodium falciparum infection with parasite density > 2000/µL
- •Fever or history of fever
- •Able to be treated by oral route
- •No signs of severe malaria
- •No known allergy to study drugs
- •No other severe illnesses or underlying diseases
- •No known pregnancy or negative urinary pregnancy test for women of child bearing age
- •No participation in another ongoing clinical study
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
排除标准
- 未提供
研究组 & 干预措施
Artesunate + Amodiaquine
Oral fixed combination of artesunate (AS) and amodiaquine (AQ)
Once daily, dose according to age
Infants 2-11 months: AS 25/AQ 67,5 mg (3 tablets/ blister)
Toddlers 1-5 years: AS 50/AQ 135 mg (3 tablets/ blister)
Children: 6-13 years: AS 100/AQ 270 mg (3 tablets/ blister)
Adults: >= 14 years: AS 100/AQ 270 mg (6 tablets/ blister)
3 day-treatment
干预措施: Artesunate + Amodiaquine (Drug)
结局指标
主要结局
Polymerase chain reaction (PCR)-corrected and uncorrected clinical and parasitological cure rate (ACPR)
时间窗: Day 28
次要结局
- Evolution of in vitro resistance rate(Day 3, Day 7, Day 14, Day 21 and Day 28)
- Number of patients without fever(Day 3)
- Number of patients without parasite(Day 3)
- Number of gametocytes(Day 3, Day 7, Day 14, Day 21 and Day 28)