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临床试验/NCT00167713
NCT00167713已完成4 期

Randomised, Double-Blind, Placebo Controlled Study of the Antipyretic Effect of Ibuprofen in Children With Uncomplicated Malaria

Albert Schweitzer Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2003年4月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
2
主要终点
Fever clearance time

研究概览

简要总结

Drugs to treat fever are widely used in children with fever. But there is a controversy about the benefit of reducing fever in children with malaria. Ibuprofen is often used to treat malarial fever. This study evaluates the capacity of ibuprofen to reduce fever in malaria. The effect of ibuprofen on fever compared to only mechanical measures is investigated in children with malaria.

详细描述

Fever is the most apparent clinical manifestation of Plasmodium falciparum infection during the acute phase. The role of fever in defence against malaria or in other infectious diseases remains unclear. However, it has been shown that febrile temperatures inhibit the growth of P. falciparum in vitro.

Antipyretic drugs are commonly and widely used to treat malarial fever in endemic areas. There is however a controversy about the benefit of reducing fever in children with malaria. Data from Gabon have revealed that neither paracetamol, nor naproxen or metamizol - antipyretics often used in this area - had an effect on fever clearance time. Worryingly, paracetamol increased parasite-clearance times (i.e. inhibited clearance of parasites) and decreased significantly the production of oxygen radicals and tumour necrosis factor (TNF), mechanisms of the innate immune response, pivotal to combat infections.

Another antipyretic drug often used to treat malarial fever in endemic areas is ibuprofen. However, the rationale of its use and its capacity of reducing fever due to P. falciparum infections has never been proven in this area.

Comparison: The effect of ibuprofen plus mechanical fever "treatment" (continuous fanning, tepid sponging, and cooling blankets) is compared to mechanical treatment alone to treat fever in children with malaria.

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
Double

入排标准

年龄范围
2 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Uncomplicated falciparum malaria
  • Asexual parasitaemia between 20,000 and 200,000/µL
  • Fever with temperature above 38 °C or history of fever during the preceding 24 hours
  • Informed consent

排除标准

  • Effective anti-malarial treatment for the present attack
  • Antipyretic use within 6 hours of presentation
  • Contraindications to the use of ibuprofen (history of asthma, dyspeptic symptoms, gastro-intestinal bleeding, or allergy to ibuprofen)
  • Mixed plasmodial infection
  • Haemoglobin < 7 g/dL
  • Packed-cell volume < 20%
  • White cell count > 16,000/L
  • Platelet count < 40,000/µL
  • Schizontaemia > 50/µL
  • Impaired consciousness
  • Convulsions or history of convulsions
  • Concomitant diseases masking assessment of response

结局指标

主要结局

Fever clearance time

Fever time

Area under the fever curve

次要结局

  • Parasite clearance time
  • Adverse event during the entire study period

研究者

申办方类型
Other

研究点 (2)

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