Severe Malaria A Research and Trials consortium - Multisite Adaptive Platform trial
- Conditions
- Malaria
- Registration Number
- PACTR202312551082722
- Lead Sponsor
- Imperial College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 450
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
Hb <6g/dl
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cerebral Malaria domain Number of witnessed seizures sufficient to start or change anticonvulsant medication;Renal Domain Area Under the Curve (AUC) for creatinine from randomisation;Anaemia domain change in haemoglobin adjusted for baseline
- Secondary Outcome Measures
Name Time Method