Efficacy and Safety of Artesunate-amodiaquine and Dihydroartemisinin-piperaquine for the Treatment of Uncomplicated Falciparum Malaria in Mainland Tanzania
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 333
- 试验地点
- 1
- 主要终点
- Adequate clinical response
研究概览
简要总结
The World Health Organization recommends regular surveillance of antimalarial efficacy to monitor the performance of different drugs. The Tanzanian National Malaria Control Programme (NMCP) in collaboration with its partners have been implementing therapeutic efficacy studies (TES) to monitor the performance of different antimalarials in the country. Most of the studies conducted in recent years focused on artemether-lumefantrine which is the first line antimalarial for the treatment of uncomplicated malaria in Mainland Tanzania. However, data on the performance of other artemisinin based combination therapy (ACTs) is urgently needed to support timely review and changes of treatment guidelines in case of drug resistance to current regimen. This study was undertaken in the same NMCP framework to assess the efficacy and safety of alternative ACTs used or with potential use in Tanzania. The study assessed the efficacy and safety of artesunate-amodiaquine (ASAQ) and dihydroartemisinin-piperaquine (DP) for the treatment of uncomplicated malaria in Tanzania. The study was undertaken at two NMCP sentinel sites of Kibaha and Ujiji from July to December 2017.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 6 months to 10 years.
- •mono-infection with P. falciparum detected by microscopy;
- •parasitaemia of 250 - 200,000/μl asexual forms;
- •presence of axillary temperature ≥37.5 °C or history of fever during the past 24 hours
- •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; and
- •Informed consent from the parents or guardians of children.
排除标准
- •mRDT negative
- •presence of general danger signs in children aged 6 months to 10 years or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1);
- •weight under 5 Kg
- •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 < 110 mm in children ≤ 59 months; or BMI of <16 in children aged 5 years and above)
- •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);
研究组 & 干预措施
single arm
Artesunate amodiaquine tablets containing 25/67.5 mg, 50/135mg and 100/270 mg base of artesunate-amodiaquine were administered according to body weight Dihrdroartemisinin piperaquine tablets containing 160/20mg and 320/40mg base of piperaquine dihydroartemisinin were administered according to body weight
干预措施: Artesunate amodiaquine (Drug)
结局指标
主要结局
Adequate clinical response
时间窗: 28 days
Proportions of patients with 100% cure before PCR correction
次要结局
- PCR corrected responses(one months after study completion)
研究者
Dr. Celine Mandara
Researcher
National Institute for Medical Research, Tanzania