Malaria
Conditions
Interventions
No seizure prophylaxis
Standard dose paracetamol
Red Cell concentrate blood transfusion
Parenteral levetiracetam
Sponsors
Imperial College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Day 28 and Day 90 readmissions and mortality ;Cerebral malaria domain outcomes • Time to fully regain consciousness (BCS 5 (the maximum score)) • Adverse events (AEs) of any grade judged related to anticonvulsants • Solicited AEs • Neurological sequalae ;Renal domain outcomes: Creatinine at 24 hours (change from baseline, adjusted for baseline) Creatinine at 48 hours (change from baseline, adjusted for baseline) Creatinine at 72 hours (change from baseline, adjusted for baseline) Renal domain safety outcomes: Change in ALT and AST (liver enzymes) at 72 hours (adjusted for baseline) Adverse events (AEs) of any grade judged related to paracetamol AEs of any grade causing a change in paracetamol administration ;Severe anaemia domain outcomes: Change in haemoglobin at 72 hours Number of additional transfusions in the acute admission Development of new profound anaemia (Hb<4g/dl) during acute admission or development of severe anaemia (Hb<6g/dl) post discharge Adverse Events (AEs) judged related to blood transfusion ;Grade 3 or 4 Adverse Events | — |
Countries
Ghana, Kenya, Mozambique, Uganda
Contacts
Public ContactEmmanuel Oguda
Trial Manager
Outcome results
None listed