PACTR201102000277177Other未知
Comparative, Open Label, Dose and Regimen Optimization Follow-up Study of Intravenous and Intramuscular Artesunate in African Children With Severe Malaria
Prof. Peter Kremsner0 个研究点目标入组 1,044 人开始时间: 2011年2月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- Other
- 发起方
- 入组人数
- 1,044
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
- 年龄范围
- 6 Month(s) 至 10 Year(s)（—）
- 性别
- All
入选标准
- •Male or female children from 6 months to 10 years.
- •Clinical diagnosis of severe Plasmodium falciparum malaria requiring hospitalization.
- •Parasitaemia (>5000 parasites per microliter on initial blood smear).
- •Availability of child's parent/guardian and their willingness to provide written informed consent in accordance with the local practice.
- •Willingness and ability to comply with the study protocol for the duration of the study.
- •Willingness to remain in the hospital for 3 days.
排除标准
- •Known serious adverse reaction or hypersensitivity to artemisinins, including artemether, dihydroartemisinins or co-artemether (artemether/lumefantrine).
- •Any underlying disease that may compromise the diagnosis and the evaluation of the response to the study medication.
- •Participation in any investigational drug study during 30 days prior to screening.
- •Adequate (according to WHO- and country specific guidelines) antimalarial treatment within 24 hours prior to admission.
研究者
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