Severe Malaria A Research and Trials consortium - Multisite Adaptive Platform trial: SMAART-MAP trial

Imperial College London0 个研究点目标入组 450 人开始时间: 2024年1月11日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•For all domains:
•1. Aged >3 months and <12 years
•2. Admitted to the paediatric ward in the last 24 hours
•3. Current or recent evidence of malaria (slide or rapid diagnostic test (RDT) positive in this admission)
•4. Guardian willing to provide consent
•Additional domain-specific inclusion criteria:
•Renal domain:
•1. Creatinine >1.5xULN on point-of-care assay or laboratory test at screening
•2. 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))
•Cerebral malaria domain:
•1. One or more reported seizures in the current episode of illness and altered consciousness (BCS=4) at screening
•2. Presence of coma (BCS =2) at screening regardless of history
•Severe anaemia domain:
•1. Hb <6g/dl
•2. 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

•Renal domain:
•1. Received paracetamol within 6 hours of screening or between screening and randomisation
•2. Known allergy to paracetamol
•3. Severe malnutrition (middle upper arm circumference MUAC<11.5cm)
•Cerebral malaria domain:
•1. Received an anticonvulsant within 6 hours of screening or between screening and randomisation.
•2. Known cerebral palsy or significant neuro-development delay
•Severe anaemia domain:
•1. Known congenital or valvular heart disease (not surgically corrected)

发起方