Malaria
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged between 3 months and 12 years admitted to the paediatric wards within the last 24h 2. Current or recent evidence of P. falciparum malaria (slide positive) 3. Clinical evidence of severe malaria (impaired consciousness or deep breathing) 4. Lactate > 2 mmol/L 5. Guardian or parent willing and able to provide consent
Exclusion criteria
Exclusion criteria: 1. Clinical evidence or a history of a bleeding/coagulation disorder 2. A comorbidity which clinician believes has a significant risk of poor outcome e.g. malignancy, end-stage renal failure, major cardiac condition 3. Thrombocytopenia (platelet count <25 x109/L).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ?APTT>2.5 x upper limit of normal 1h post any sevuparin dose | — |
Secondary
| Measure | Time frame |
|---|---|
| ? Change in lactate from 0 to 8 hours;Presence of mature infected erythrocytes on the blood films at 8 and 24 hours;APTT 24h post enrolment ;Neurological sequelae through day 28;Mortality to Day 28;Serious adverse events through day 28 Grade 3/4 adverse events through day 28 | — |
Countries
Kenya, Zambia
Contacts
Clinical Trial Manager