NCT00540410已完成4 期
A Randomized Study to Compare Artesunate + Amiodaquine Versus Artemether + Lumefantrine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks Occurring During 2 Years in a Cohort in Senegal
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- PCR corrected and uncorrected clinical and parasitological cure rate
研究概览
简要总结
Primary objective: to demonstrate the non-inferiority of PCR adjusted adequate clinical and parasitological response at D28 of artesunate + amiodaquine versus artemether + lumefantrine, based on the first malaria attack of each subject.
Secondary objectives:
For the first attack: To compare the two groups of treatment in terms of:
- D14 efficacy
- Parasitological and fever clearance
- Clinical and biological tolerability
- Evolution of gametocyte carriage
- Cardiac tolerability (QTc)
For the repeated attacks: To compare the two groups of treatment in terms of:
- D14 and D28 clinical and parasitological effectiveness (PCR adjusted)
- Clinical and biological tolerability
- Proportion of patients without fever at D3
- Proportion of patients without parasite at D3
- Compliance
- Impact on anaemia
During the total follow-up of the cohort: To compare the two groups of treatment in term of:
- Treatment incidence density
- Impact of repeated treatment on clinical and biological safety
- Impact of repeated treatment on hearing capacity
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults or children weighting more than 5 kg
- •axillary temperature >=37.5°C at D0 or history of fever within the previous 24hrs
- •confirmed Plasmodium falciparum monoinfection, with parasitemia>1000mcl
- •negative urinary pregnancy test for women of child bearing age before each new administration of treatment
排除标准
- •presence of any serious or clinical danger sign of malaria: prostration, consciousness disorders, recent and repeated convulsions, respiratory distress, inability to drink, uncontrollable vomiting, macroscopic haemoglobinuria, jaundice, haemorrhagic shock, systolic BP< 70 mmHg in adults or < 50 mmHg in children, spontaneous bleeding, inability to sit or stand
- •severe concomitant disease
- •allergy to one of the investigational drugs.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
干预措施: Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination) (Drug)
2
Active Comparator
干预措施: Coartem® (arthemether+ lumefantrine) (Drug)
结局指标
主要结局
PCR corrected and uncorrected clinical and parasitological cure rate
时间窗: at D28 and for the first attack
次要结局
- PCR corrected and uncorrected clinical and parasitological cure rate(at D28 and for the next attacks)
- Fever and parasitological clearance(first attack)
- Proportion of afebrile patients and proportion of patients without parasites(at D3 for the following attacks)
- Clinical tolerability (incidence and intensity of recorded AE)(during the study period)
- Biological tolerability (Hb, bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count)(during the study period)
- Cardiac tolerability (QTc) for the first attack in patients group aged >= 12 years)(at the time of the first attack)
- Assessment and evolution of hearing function in patients groupe aged >=12 years(during the study period)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Efficacy and Tolerability of Artesunate Amodiaquine Versus Chloroquine in the Treatment of Uncomplicated Plasmodium Vivax MalariaMalariaNCT01378286Sanofi380
撤回
4 期
Efficacy of Artesunate-amodiaquine (AS-AQ) in Children With Malaria and Severe Acute Malnutrition, Madaoua, Niger 2010Malaria, FalciparumMalnutritionChildNCT01204411Epicentre
已完成
4 期
Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLeranceMalariaNCT00445796Sanofi300
已完成
4 期
Efficacy and Safety of Artesunate + Amodiaquine With SLD of Primaquine for Treatment of Falciparum Malaria in ZanzibarPlasmodium Falciparum MalariaNCT03773536Professor Anders Björkman146
已完成
4 期
Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for Uncomplicated Malaria in South Kivu, DR CongoMalariaNCT02741024Medecins Sans Frontieres, Netherlands288