Efficacy and safety of artemether-lumafantrine and dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum in children aged 6 to 59 months at two sentinel sites in Togo
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 357
研究概览
简要总结
One hundred seventy-nine and 178 children were included in the artemether-lumefantrine and dihydroartemisinin-piperaquine arms, respectively. At follow-up on day 28, 98% or more of the children treated with artemether-lumefantrine were cured. Among children treated with dihydroartemisinin-piperaquine, 99% or more were cured at day 42. All patients in both arms were free of parasites at day 3. Minor adverse events, including vomiting and loss of appetite, were reported. None of the 357 day 0 samples carried the marker (K13 mutation) associated with partial artemisinin resistance. No markers associated with antimalarial drug resistance were observed. The results of this study support the continued use of first-line therapies for uncomplicated falciparum malaria and sulfadoxine/pyrimethamine for intermittent preventive treatment during pregnancy. The dihydroartemisinin-piperaquine combination was also very effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 6 Months 至 59 Months（—）
- 性别
- All
入选标准
- •age from six to 59 months
- •mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection);
- •parasitaemia of 2000–200,000 per micrometer asexual forms;
- •Presence of axillary or tympanic temperature greater or equal to 37.5 degrees centigrade or history of fever during the past 24 h;
- •ability to swallow oral medication;
- •ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
- •informed consent from parent or guardian.
排除标准
- •presence of general danger signs in children aged between 6 to 59 months or signs of severe falciparum malaria according to the definitions of WHO.
- •weight under 5 kg;
- •haemoglobin below 8 g per dl;
- •mixed or mono-infection with another Plasmodium species detected by microscopy;
- •presence of severe malnutrition defined as a child who has symmetrical oedema involving at least the feet or has a mid-upper arm circumference below 110 mm in children greater.
- •presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
- •regular medication, which may interfere with antimalarial pharmacokinetics;
- •history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);