Efficacy of dual parenteral artemisinin-based combination therapy for cerebral malaria in a randomized control trial in Nigerian children.
Not Applicable
- Conditions
- Malaria
- Registration Number
- PACTR202102893629864
- Lead Sponsor
- Alao Michael and Co Authors
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 359
Inclusion Criteria
1.Children between the ages of 6 months to 17 years as at the last birthday
2.Children with unarousable coma lasting more than 30 minutes in the presence of demonstratable peripheral asexual P. falciparum parasitemia.
3.Children who develop deterioration in their level of consciousness after admission and demonstrate asexual Plasmodium falciparum in the peripheral blood.
Exclusion Criteria
1.Children with positive biochemical and/or microbiological CSF result consistent with a diagnosis of meningitis
2.Children who have intracranial infections or intracranial space-occupying lesions
3.Children with previous neurological deficit either focal or global
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome of this study is the effectiveness of dual parenteral antimalaria in the treatment of cerebral malaria compared to the standard of care in terms of survival and full recovery in tertiary hospitals in Nigeria.
- Secondary Outcome Measures
Name Time Method The secondary outcomes include the parasite clearance rate, fever defervescence, time to recovery of consciousness, and the side effect profile of interventions (treatment and control arms).