ISRCTN59761234已完成未知
Assessing the efficacy of Dihydroartemisinin-piperaquine in African patients suffering of uncomplicated falciparum malaria and to determine the pharmacokinetics profile of piperaquine in children 2 - 10 years old presenting falciparum malaria
Beijing Holley-Cotec Pharmaceuticals Co. Ltd (China)0 个研究点目标入组 330 人开始时间: 2008年2月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 330
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
- •On day 0, patients with symptoms suggestive of malaria and a positive screening thick blood smear will be assessed for the following selection criteria by study physicians for appropriate care:
- •1. Not previously enrolled in this study
- •2. 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 42-day follow-up (patient has easy access to health unit)
- •8. No history of antimalarial use in the previous two weeks (except for chloroquine)
- •9. No danger signs or evidence of severe malaria defined as:
- •9.1. Unarousable coma (if after convulsion, greater than 30 minutes)
- •9.2. Recent febrile convulsions (within 24 hours)
- •9.3. Altered consciousness (confusion, delirium, psychosis, coma)
- •9.4. Lethargy
- •9.5. Unable to drink or breast feed
- •9.6. Vomiting everything
- •9.7. Unable to stand/sit due to weakness
- •9.8. Severe anaemia (haemoglobin [Hb] less than 5.0 gm/dL)
- •9.9. Respiratory distress (laboured breathing at rest)
- •9.10. Jaundice
- •After going to the laboratory, the subjects will be referred to the study nurse for treatment allocation and treatment with the study medications. Patients must also meet the following criterion:
- •10. Absence of repeated vomiting of study medications on day 0
- •Patients will return to the clinic on day 1 and will be excluded from the study if the following inclusion criteria are not met:
- •11. Plasmodium falciparum mono-infection
- •12. Parasite density 2000 - 200,000/ul
排除标准
- •1. Inhability to participate in 42 days follow up
- •2. Pregnant women
- •3. Severe malaria
研究者
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