Malaria
Conditions
Interventions
BiCurass Ventilation
Leveteracitam low dose
Leveteracitam high dose
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 3 months to 12-years 2. Hospitalised with: 2.1. Current or recent evidence of P. falciparum malaria (slide or rapid diagnostic test (RDT) positive) 2.2. Blantyre Coma Score 2 or less that persists even after correction for concurrent hypoglycaemia (defined as blood glucose <3 mmol/L) 2.3. History of seizures in this illness
Exclusion criteria
Exclusion criteria: 1. Known cerebral palsy or significant neuro-development delay (which will affect endpoint assessment) 2. Skin disease or burns preventing use of the BCV 3. Respiratory or cardio-respiratory arrest prior to enrolment 4. A comorbidity which clinician believes has a significant risk of poor outcome e.g. malignancy, end-stage renal failure, major cardiac condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Cumulative time with epileptogenic seizure activity will be determined by continuous EEG monitoring over 36 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility will be assessed by ability to implement/operationalise the BCV for use on the high dependency ward in Kilifi County Hospital (assessed by whether this can generate negative pressure ventilation as per specification by the Hayek recommendations and averts respiratory safety endpoints). ;Safety Assessed by 1. Episodes of aspiration (determined by sudden decrease in oxygen saturations, and/or denovo presence of coarse chest crepitations, with evidence of gastric reflux/aspirate in the oropharynx). 2. Episodes of hypercarbia (defined as pCO2 level of greater than 45 mmHg). 3. Episodes of bradypnoea (defined as 36m respectively) and hypoxaemia (oxygen saturation <92%). 4. Development of hypotension (defined as systolic blood pressure <50 mm Hg in children younger than 12 months; <60 mm Hg in children 1-5 years and <70 mm Hg in children olderthan 5 years of age). 5. Use of additional anticonvulsants. ;Day 28 and day 180 mortality;Neurocognative Sequelae;Re-admission to hospital through day 180;Grade 3/4 adverse events through day 180;Length of initial hospitalisation | — |
Countries
Kenya
Contacts
Public ContactPhyles Maitha
Trial administrator
Outcome results
None listed