DON in Pediatric Cerebral Malaria
DON in Pediatric Cerebral Malaria: A Phase I/IIa Dose-Escalation Safety Study
Douglas Postels, MD, MS
152 participants
Aug 16, 2022
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to evaluate the safety of a single intravenous dose of DON in healthy adults, adults with uncomplicated malaria, and children 12 months-14 years old with clinically defined Cerebral Malaria. The main objectives are: * Determine the pharmacokinetic (PK) profile of a single dose of DON in children with CM * Determine if administration of a single intravenous dose of DON as an adjunctive therapy in children with CM is associated with improved intracerebral blood flow dynamics on transcranial doppler (TCD) * Determine if administration of a single intravenous dose of DON as an adjunctive therapy in children with CM is associated with a reduction in brain volume score on magnetic resonance imaging (MRI) * Determine if administration of a single intravenous dose of DON as an adjunctive therapy in children with cerebral malaria is associated with changes in electroencephalogram (EEG) pattern * Exploratory: Explore the metabolic mechanisms of action of adjunctive DON in children with CM Healthy adult participants will receive: * anti-emetic ondansetron * one dose of DON Adults with uncomplicated malaria will receive: * anti-emetic ondansetron * one dose of DON * artemisinin-combination therapies per Malawi Ministry of Health guidelines Pediatric participants will receive: * one dose of DON * anti-emetic ondansetron and per Malawi Ministry of Health guidelines: * enteral lumefantrine-artemether therapy, and * artesunate therapy
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Single intravenous dose ranging from 0.1-10 mg/kg per dose
Single intravenous dose of saline
Single intravenous dose ranging from 0.1-1.0 mg/kg per dose
Locations(2)
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NCT05478720