The Effect of Paracetamol in the Treatment of Non-severe Malaria in Children in Guinea-Bissau
试验速览
- 阶段
- 4 期
- 试验地点
- 1
- 主要终点
- parasite clearance time
研究概览
简要总结
The National Malaria Programme in Guinea-Bissau recommends paracetamol for all children treated for malaria. We, the investigators of the Bandim Health Project, want to evaluate whether this treatment has any effect on:
- the well-being of the child;
- the parasite clearance time; and
- the rate of a re-appearance of parasites during 35 days of follow-up.
Children presenting at Bandim Health Centre with malaria will be treated with chloroquine plus paracetamol or chloroquine plus placebo. Blood samples will be obtained daily for the first 4 days and then once a week until day 35.
详细描述
A Cochrane Review was unable to show a superior antipyretic effect of paracetamol compared with placebo in febrile children. Recent research suggests that the time to parasite clearance in non-severe malaria is longer in children being given paracetamol. As the costs associated with the use of paracetamol is not trivial and the risk of adverse effects is not negligible, we want to evaluate the effects of paracetamol on:
- the well-being of the child;
- the parasite clearance time; and
- the recrudescence rate.
Children presenting at Bandim Health Centre with symptoms of malaria and a malaria film showing mono-infection with P.falciparum will, following consent to participate, randomly be allocated to treatment with chloroquine and paracetamol or with chloroquine and placebo.
Blood samples will be obtained daily for the first 4 days. The children will be visited and a malaria film taken on day 7 and then weekly until day 35. On inclusion and whenever parasitaemia is detected a capillary blood sample will be taken for PCR analyses to be able to distinguish re-infection from recrudescence.
During follow-up children are recommended to present at the health centre in case of persistent fever or any other symptoms. Examination and treatment will be free of charge. Whenever a child has re-infection sulfadoxine/pyrimethamine will be used for re-treatment following the recommendation of the National malaria Programme.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •< 15 years of age
- •Presenting at Bandim Health Centre
- •Symptoms suggestive of malaria
- •At least 20 P. falciparum parasites per 200 leukocytes
- •Live in Bandim (to enable follow-up)
排除标准
- •Severely ill children considered to need the services of a hospital by the doctor in charge
- •Previous idiosyncratic reactions to chloroquine or paracetamol
研究组 & 干预措施
1 Paracetamol
Paracetamol as per protocol
干预措施: acetaminophen (paracetamol) (Drug)
2 Placebo
Inactive placebo as per protocol.
干预措施: Placebo (Other)
结局指标
主要结局
parasite clearance time
时间窗: 35 days
recrudescence rate
时间窗: 35 days
次要结局
- well-being of the child(35 days)