ACTRN12622000944730已完成4 期
Efficacy and safety Study of Artesunate+Sulphadoxine/Pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria and Chloroquine for Plasmodium vivax malaria in health facilities of Nangarhar and Laghman provinces of Afghanistan
Ministry of Public Health Afghanistan0 个研究点目标入组 243 人开始时间: 2022年7月4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
- 243
研究概览
简要总结
One hundred twenty-three patients (63 from Laghman and 60 from Nangarhar) infected with P. falciparum were treated with artesunate+sulfadoxine/pyrimethamine (ASSP), and 120 patients with P. vivax (60 from Laghman and 60 from Nangarhar) were treated with chloroquine (CQ). The data from Nangarhar, for both the ASSP and CQ groups, were invalidated during blood sample quality control. Of the 60 patients treated with artesunate+sulfadoxine/pyrimethamine in Laghman, 57 met the study endpoints, and all had achieved adequate clinical and parasitological response. Similarly, all P. vivax patients treated with CQ achieved adequate clinical and parasitological response. No adverse events were recorded. No mutations for artemisinin, piperaquine, or mefloquine resistance were detected in samples form the patients with P. falciparum.
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
- •1.age above 6 months, excluding female minors aged 12-15 years and unmarried women for the falciparum study
- •2.mono-infection with P. falciparum or P. vivax detected by microscopy;
- •3.parasitaemia of 500-200,000 per microL asexual forms
- •4.presence of axillary temperature greater or equal to 37.5 degrees centigrade or history of fever during the past 24 h
- •5.ability to swallow oral medication
- •6.ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
- •7.Informed consent from the patient, or from a parent or guardian in the case of children under 16 years of age
- •8.Informed assent from any minor participant in the P. falciparum study aged from 12 to 15 years
- •9.Consent for pregnancy testing from married female of child-bearing age for the P. falciparum sub-study
排除标准
- •1.presence of general danger signs in children aged under 5 years and adults or signs of severe falciparum malaria according to the definitions of WHO
- •2.Weight under 5 kg
- •3.mono-infection of P. malariae or mixed with another Plasmodium species detected by microscopy
- •4.Presence of severe malnutrition (defined as a child who has a mid-upper arm circumference below 110 mm)
- •5.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)
- •6.regular medication, which may interfere with antimalarial pharmacokinetics;
- •7.history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
- •8.a positive pregnancy test or breastfeeding for potential participants in the P. falciparum group
- •9.unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age and who are sexually active for the falciparum group
研究者
相似试验
已完成
不适用
SPK Study in AfghanistanUncomplicated P. Falciparum MalariaNCT01707199University of Oxford83
已完成
不适用
Artesunate+Sulfadoxine-Pyrimethamine for the Treatment of Uncomplicated Falciparum MalariaFalciparum MalariaNCT01115439University of Oxford100
招募中
不适用
Efficacy and safety of Artesunate plus Sulphadoxine-Pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria in malaria control center Asadabad in Kunar province of AfghanistaACTRN12612001049864Research Department, Ministry of Publich Health, Afgahnistan88
已完成
4 期
Efficacy and safety of artesunate+sulfadoxine/pyrimethamine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in At Tur Bani Qa'is, Harad, Almusaymir, Jabal Ash Sharq, Al Udayn and Bajil districts in YememalariaInfection - Studies of infection and infectious agentsPublic Health - EpidemiologyACTRN12610000696099Ministry of Public Health and Population522
已完成
4 期
Efficacy and safety of artesunate+sulfadoxine/pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria in Kassala (Kassala State), Kosti (White Nile state), Sinnar (Sinnar State), Damazin (Blue Nile State), SudaInfection - Studies of infection and infectious agentsMalariaACTRN12611001253998Federal Ministry of Health of Sudan352