Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate in Treatment of Severe Malaria in Ugandan Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters; total area under the plasma concentration vs. time curve (AUC) of artesunate and DHA, maximum plasma concentration (Cmax), time to attain maximum concentration, elimination half life
研究概览
简要总结
Intravenous artesunate is highly effective with rapid schizonticidal action and improved clinical outcome
详细描述
The current first line treatment for severe malaria in Uganda is intravenous quinine with artemisinin derivatives as an alternative. Intravenous artesunate, a water soluble artemisinin derivative is more effective than quinine with faster schizonticidal action and improved clinical outcome. It is generally well tolerated and safe. This study aims is to assess the pharmacokinetics, pharmacodynamics and safety of IV artesunate in treatment of severe malaria in adults admitted to Mulago National Referral and Teaching hospital, Uganda.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and above
- •With severe malaria according to the following ciriteria:
- •A positive blood smear for malaria with P. falciparum mono-infection with parasitemia > 500 parasites/ul of blood
- •Who according to the attending physician require parenteral treatment and admission for malaria
- •Willing to participate in the study
- •Who are or whose first degree parents/caretakers are able to provide written informed consent
排除标准
- •Patients with history of prior antimalarial use within the last 72 hours
- •Pregnant women
- •Patients with contraindications to taking the study drugs
- •Patients taking known inhibitors or inducers of cytochrome P450 -
研究组 & 干预措施
20 adults with severe malaria
20 adult patients admitted with severe malaria
干预措施: intravenous artesunate (Drug)
结局指标
主要结局
Pharmacokinetic parameters; total area under the plasma concentration vs. time curve (AUC) of artesunate and DHA, maximum plasma concentration (Cmax), time to attain maximum concentration, elimination half life
时间窗: 6 hours
Pharmacokinetic parameters for artesunate and dihydroartemisinin
次要结局
- Time to 50% parasite clearance (PCT50)(7 days)