An Open Randomised Trial of the Efficacy of Sulfadoxine-Pyrimethamine (SP), Amodiaquine + SP (AQ-SP), AQ + Artesunate (AQ-Art), Chlorproguanil-Dapsone + Art (CD-Art), and Lumefantrine-Artemether (LA) for Uncomplicated Malaria in Malawi
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 365
- 试验地点
- 3
- 主要终点
- • Rate of Adequate Clinical and Parasitological Response at 14 days (WHO-defined measure of efficacy)
研究概览
简要总结
Sulfadoxine-pyrimethamine (SP) is the current first-line treatment for uncomplicated malaria in Malawi. The malaria parasite P. falciparum has developed resistance to this drug so that the drug is much less effective than in previous years. This study was developed and conducted in collaboration with the National Malaria Control Programme of Malawi to assess the efficacy of four antimalarial drug combinations to provide evidence to assist the Malawian Ministry of Health in identifying and implementing as policy the next first-line antimalarial for uncomplicated malaria in Malawi. In an open, randomized trial in children under five years of age, four drug combinations, all of which are licensed in Malawi, are being assessed: amodiaquine plus sulfadoxine-pyrimethamine (AQ-SP), amodiaquine plus artesunate (AQ-Art), chlorproguanil-dapsone plus artesunate (CD-Art) and lumefantrine-artemether (LA). SP is also included as a fifth arm of the study for current data on its efficacy. Data on side effects of the drugs will also be collected. The results of this study will provide some of the information necessary to guide the Malawi National Malaria Control Program in selecting its next first antimalarial treatment for uncomplicated malaria. The study adheres to the World Health Organization's 2003 standardized protocol for assessing antimalarial drug efficacy.
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
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children age 6 - 59 months
- •Axillary temperature ≥ 37.5 °C
- •Monoinfection with P. falciparum
- •Parasitaemia between 2000 - 200000 parasites/µl
- •Haemoglobin concentration (finger-prick blood sample by HemoCue) > 7g/dl
- •Consent by the patient's adult guardian
- •Residence in the locality and willingness to attend for scheduled visits
排除标准
- •altered consciousness
- •convulsions
- •prostration (inability to sit/stand/suck/drink)
- •respiratory distress or breathlessness
- •abnormal breathing
- •haemoglobinuria
- •circulatory collapse
- •persistent vomiting (cannot keep down liquids)
- •evidence of a diagnosis other than malaria on physical examination
- •presence of mixed infection
- •presence of severe malnutrition (as evidenced by symmetrical oedema involving at least the feet, light hair color, or cachexia)
- •contraindications to the antimalarial drugs used, especially history of allergy
- •history of receiving a drug with antimalarial activity in the week prior to enrollment
结局指标
主要结局
• Rate of Adequate Clinical and Parasitological Response at 14 days (WHO-defined measure of efficacy)
次要结局
- • Rate of Late Clinical Failure (as defined by the WHO)
- • Rate of Adequate clinical and parasitological response 28 days
- • Mean percent change in blood haemoglobin concentration between day 0 and day 28
- • Percent of patients with a decrease in haemoglobin concentration of ≥ 2g/dl
- • Rate of Late Parasitologic Failure (as defined by the WHO)
- • Incidence of adverse events during the period of observation
- • Rate of Early Treatment Failure (as defined by the WHO in their 2003 standardized protocol for assessing antimalarial drug efficacy)
- • Prevalence of parasitemia on Day 2
- • Percent of patients with a decrease in haemoglobin concentration
- • Prevalence of parasitemia on Day 3
- • Gametocyte prevalence on Day 14
- • Gametocyte prevalence on Day 28