ACTRN12624000526572已完成4 期
Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Al Tor Bin Qais in Hajah, Yemen.
The Ministry of Public Health and Population0 个研究点目标入组 88 人开始时间: 2024年4月27日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
研究概览
简要总结
Eighty-eight patients were enrolled in the study. All patients completed the 28 days follow-up, and all achieved adequate clinical and parasitological response showing 100% cure rate. No adverse events were reported. All but one patient (1.1%) were free of parasites at day 3. Samples on day 0 are being analyzed for mutations in K13 mutation known to be associated with artemisinin partial resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 6 Months 至 o limit（—）
- 性别
- All
入选标准
- •age between 6 months and above, excluding female minors 12-17 years old and unmarried females aged 18 years and above;
- •mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection);
- •parasitaemia of 500-200000 per micrometer asexual forms;
- •presence of axillary temperature greater or equal 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 the patient or from a parent or guardian in the case of children aged less than 18 years;
- •informed assent from any minor participant aged from 12 to age of majority years; and
- •consent for pregnancy testing from married female aged 18n years and above.
排除标准
- •presence of general danger signs in children aged under 12 years or signs of severe falciparum malaria according to the definitions of WHO;
- •female aged from 12 years and below 18 years;
- •weight under 5 kg;
- •haemoglobin below 8 g per deciliter;
- •mixed or mono-infection with another Plasmodium species detected by microscopy;
- •presence of severe malnutrition defined as a child aged between 6-60 months who has a mid-upper arm circumference below 115 mm);
- •presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea 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);
- •a positive pregnancy test or breastfeeding; and
- •unable to or unwilling to take pregnancy test or to use contraception for married aged 18 years and above.
研究者
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