PACTR202312551082722尚未招募2 期
Severe Malaria A Research and Trials consortium - Multisite Adaptive Platform trial SMAART-MAP trial
Imperial College0 个研究点目标入组 450 人开始时间: 2023年11月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 450
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
- 1 Month(s) 至 23 Month(s)（—）
- 性别
- All
入选标准
- •Admitted to the paediatric ward in the last 24 hours
- •Current or recent evidence of malaria (slide or rapid diagnostic test (RDT) positive in this admission)
- •Guardian willing to provide consent
- •Domain Specific criteria
- •Cerebral Malaria Domain
- •EITHER One or more reported seizures in the current episode of illness and altered consciousness (BCS=4) at screening
- •OR Presence of coma (BCS =2) at screening regardless of history
- •Renal domain
- •Creatinine >1.5xULN on point-of-care assay at screening
- •Meet one of the current WHO severity criteria (clinical or laboratory (where these tests are done routinely)) (Group 1 and 2 from the recent WHO reclassification of severe malaria)
- •Anaemia Domain
- •One or more or the following severity signs: Hb<4g/dl, prostration, impaired consciousness, respiratory distress, history of passing red or coca-coloured urine in this illness
排除标准
- •Domain Specific criteria
- •Cerebral Malaria Domain
- •Received an anticonvulsant within 6 hours of screening or between screening and randomisation.
- •Known cerebral palsy or significant neuro-development delay.
- •Renal Domain
- •Received paracetamol within 6 hours of screening or between screening and randomisation
- •Known allergy to paracetamol
- •Severe malnutrition (middle upper arm circumference MUAC<11.5cm)
- •Anaemia Domain
- •Known congenital or valvular heart disease (not surgically corrected)
研究者
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