A Randomised Safety and Efficacy Trial of Rifampicin/Cotrimoxazole/Isoniazid Versus Mefloquine or Quinine+SP Against Resistant Malaria in Papua New Guinea
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Incidence of adverse events.
研究概览
简要总结
The purpose of this study was to assess the safety and efficacy of Cotrifazid to treat uncomplicated resistant malaria and to compare the outcome with mefloquine or quinine+sulfadoxine/pyrimethamine (SP)
详细描述
Design: Open-label, block-randomised, comparative, multicentric trial. Setting: Four primary care health facilities, two in urban and two in rural areas of Madang and East Sepik Province, Papua New Guinea.
Participants: Patients of all ages with recurrent uncomplicated malaria Intervention: Random assignment to receive either Cotrifazid, mefloquine or the standard treatment of quinine+sulfadoxine/pyrimethamine (SP).
Outcome measures: Incidence of clinical and laboratory adverse events; rate of clinical and/or parasitological failure at day 14
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects > 6 months of age who presented at the centres and who were diagnosed with malaria (history of fever, OptiMAL® test positive, no other major symptom) and who had already been treated for malaria in the 28 days before, could be included in the study, if the subject or legal guardian (for children) gave informed consent and if the clinician in charge would have given the standard treatment for resistant malaria independent of the study -
排除标准
- •A subject was not to be included if the clinician preferred to use quinine for whatever reason, if the patient had one of the symptoms or signs of complicated or severe malaria (i.e. history of recent convulsion, any neurological sign or impairment of consciousness, heavy vomiting, haemoglobinuria, respiratory distress, bleeding, circulatory collapse, shock, jaundice, haemoglobin < 5 g/dl), had contra-indications for mefloquine (history of psychiatric disorder, epilepsy), or was pregnant.
结局指标
主要结局
Incidence of adverse events.
Clinical treatment failure rate on day 14.
次要结局
- Parasitological failure rate on day 14
- Fever clearance time
- Parasite clearance time
- Symptoms clearance time
- Occurrence of complications