A Randomised Controlled Trial to Assess the Antimalarial Drug Susceptibility and Molecular Characterization of Plasmodium Vivax Isolates in Vietnam
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Proportion of patients with adequate response to treatment
研究概览
简要总结
This is a study of drug effectiveness for 2 treatments of vivax malaria, which is one of the two main types of malaria in Viet Nam. There are two important drugs used in Viet Nam for treating vivax malaria, Chloroquine and Artemisinin. Sometimes, when medicines are used for many years they become less effective at treating a disease, especially when they are not used at adequate doses according to national guidelines or when counterfeit drugs are available in the market. The purpose of this study is to check that Chloroquine and Artemisinin, are still effective for patients in Viet Nam.
Participants in this study will be treated with either Dihydroartemisinin-Piperaquine (DHA-PPQ) or Chloroquine (CQ) for 3 days. Both drugs are recommended by the national guidelines to treat vivax malaria. The investigators would like to know if both of these treatments are equally effective so half of the patients in the study will be treated with DHA-PPQ and the other half will be treated with CQ. This way the investigators can compare the drugs to find out if one is better than the other.
Participants will be followed for 3 days in hospital, then regularly by follow-up visits until the 63rd day. Tests will be done to determine the amount of drug and malaria parasites in the participant's body and how the blood cells react to the malaria. The parasite will be tested to determine what type it is and how it reacts to the treatment.
The results of the study will be used to inform malaria treatment guidelines in Viet Nam.
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
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 3 years;
- •Mono-infection with P. vivax, parasitemia > 250/µl asexual forms for in vivo and >8000 asexual parasites/µl blood for in vitro testing;
- •Presence of axillary or tympanic temperature ≥ 37.5 °C 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/assent
排除标准
- •Presence of general danger signs or severe malaria according to the definitions of WHO (2000);
- •Mixed infection with P.falciparum and P.vivax of other plasmodium species;
- •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;
- •Received antimalarial drugs in the previous 48 hours;
- •History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
- •Splenectomy;
- •First trimester of pregnancy.
研究组 & 干预措施
Chloroquine
25mg base/kg for 3 days
干预措施: Chloroquine (Drug)
Dihydroartemisinin/Piperaquine
Dihydroartemisinin 40 mg + piperaquine phosphate 320 mg per tablet; once daily for three days, doses depend on weight
干预措施: Dihydroartemisinin/Piperaquine (Drug)
结局指标
主要结局
Proportion of patients with adequate response to treatment
时间窗: Day 63
Adequate response = adequate clinical and parasitological response. Absence of parasitaemia on day 63, irrespective of temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure.
次要结局
- Fever clearance time(Assessed every 6 hours until Day 3, or 24 hours without fever)
- The parasite clearance time(Assessed every 6 hours until Day 3, or two consecutive parasite negative slides.)
- Proportion of patients classified as Early Treatment Failures(Day 63)
- Proportion of patients classified as Late Clinical Failures(Day 63)
- Proportion of patients classified as Late Parasitological Failures(Day 63)
- Frequency of adverse and serious adverse events(Day 63)