In Vivo and in Vitro Efficacy of the Recommended First Line Antimalarial Treatments (Artemether-Lumefantrine and Amodiaquine-Artesunate) in Children With Uncomplicated Malaria in Burkina Faso
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Centre Muraz
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- PCR unadjusted treatment failure (regardless of genotyping).
研究概览
简要总结
Resistance to antimalarial drugs represents a major obstacle for controlling malaria in endemic countries, so that most sub-Saharan countries have changed their antimalarial drug policy to the new Artemisinin Containing Therapies. Burkina Faso has changed its policy for uncomplicated malaria to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS), but there are still little available data on safety and efficacy of these treatments in Burkina Faso; both treatments have shown to be efficacious, but AL seems to have higher occurrence of recurrent malaria infections during a 28-day follow up period. Thus, this study aims at comparing the safety and efficacy of AL and AS-AQ (42-day follow-up), AND also at comparing their in vitro sensitivity, in patients with recurrent infection, with the results obtained in vivo.
详细描述
Plasmodium falciparum resistance to antimalarial drugs represents the major drawback and obstacle for controlling malaria in endemic countries; that's why most sub-Saharan countries have changed their antimalarial drug policy to Artemisinin Containing Therapies (ACT), which produce a rapid clinical and parasitological cure, reduce gametocyte carriage rate and are generally well tolerated. Burkina Faso has recently changed its policy for the treatment of uncomplicated malaria, from Chloroquine to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS). However, there are still little available data on safety and efficacy of these treatments in Burkina Faso; a recent study carried out in Bobo Dioulasso showed that both treatments were extremely efficacious (adjusted treatment failure less than 5%) but with AL showing significantly high occurrence of recurrent infections during the 28-day follow up period. The higher risk for recurrent infections for AL was confirmed in a subsequent trial comparing AL with AQ-SP and dihydroartemisinin-piperaquine, but so far no direct comparison between AQ+AS and AL has been completed, though a study in Nanoro, near Ouagadougou, is ongoing. Thus, the present study aims at comparing the in vivo safety and efficacy of AL and AS-AQ (42-day follow-up),AND at comparing the in vitro sensitivity of the different ACT components, in patients with recurrent infection, with the results obtained in vivo.
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 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 - 59 months
- •Weight > 5 kg
- •Mono-infection with P. falciparum
- •Parasitemia of 4,000-200,000 asexual parasites per µl
- •Fever: > 37.5 °C or history of fever in the preceding 24 hours
- •Haemoglobin > 5.0 g/dl
- •Signed informed consent by the parents or guardians
- •Parents' or guardians' willingness and ability to comply with the study protocol for the duration of the trial.
排除标准
- •Participation in any other clinical trial during the previous 30 days
- •Known hypersensitivity to the study drugs
- •Severe and/or complicated malaria (cases will be referred to Bobo-Dioulasso University hospital for treatment)
- •Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand;
- •Known intercurrent illness or any condition which would place the subject at undue risk or interfere with the results of the study.
- •Severe malnutrition (weight for height <70% of the median NCHS/WHO reference)
研究组 & 干预措施
Artemether -lumefantrine
Treatment of malaria with Artemether-lumefantrine (AL), according to one of the two options given by national protocol in Burkina Faso
干预措施: Artemether-lumefantrine (Drug)
Artesunate-amodiaquine
Treatment of malaria with Artesunate-amodiaquine(AS-AQ), according to one of the two options given by national protocol in Burkina Faso
干预措施: Artesunate-amodiaquine (Drug)
结局指标
主要结局
PCR unadjusted treatment failure (regardless of genotyping).
时间窗: 42 days
次要结局
- Asexual parasite clearance time(day 7, 14, 21, 28, 35, 42)
- Parasites in vitro sensitivity to the drugs tested and their relationship with the in vivo results(before treatment and at the day of reccurrente parasitemia)
- PCR adjusted treatment failure(28 days)
- PCR unadjusted treatment failure(28 days)
- Fever clearance time(day 1, 2, 3)
- Gametocytaemia (prevalence and density)(Day 7, 14, 21, 28, 35 and 42)
- Safety profiles of the two treatments(42 days overall)