ISRCTN71912942已完成不适用
Assessment of first line therapy for uncomplicated falciparum malaria with artemether/lumefantrine (Coartem®) and artesunate/amodiaquine (Coarsucam®) in Bobo-Dioulasso, Burkina Faso: a randomised controlled trial
Institute of Research in Health Sciences (Institut de Recherche en Sciences de la Santé [IRSS]) (Burkina Faso)0 个研究点目标入组 197 人开始时间: 2010年6月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 197
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Not previously enrolled in this study
- •2. Both males and females, aged greater than 6 months
- •3. Weight greater than 5 kg
- •4. Fever (greater than 37.5ºC axillary) or history of fever in the previous 24 hours
- •5. Absence of any history of serious side effects to study medications
- •6. No evidence of a concomitant febrile illness in addition to malaria
- •7. Provision of informed consent and ability to participate in 28-day follow-up (patient has easy access to health unit)
- •8. No danger signs or evidence of severe malaria defined as:
- •8.1. Unarousable coma (if after convulsion, greater than 30 minutes)
- •8.2. Repeated convulsions (greater than two within 24 hours)
- •8.3. Recent convulsions (one to two within 24 hours)
- •8.4. Altered consciousness (confusion, delirium, psychosis, coma)
- •8.5. Lethargy
- •8.6. Unable to drink or breast feed
- •8.7. Vomiting everything
- •8.8. Unable to stand/sit due to weakness
- •8.9. Severe anaemia (Hb less than 5.0 g/dL)
- •8.10. Respiratory distress (laboured breathing at rest)
- •8.11. Jaundice
- •9. Plasmodium falciparum mono-infection
- •10. Parasite density greater than 2,000/ul and less than 200,000/ul
排除标准
- •1. Severe malaria
- •2. Unable to comply with planned follow up
- •3. Pregnancy
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