RecruitingPhase 1Phase 2NCT05478720

DON in Pediatric Cerebral Malaria

DON in Pediatric Cerebral Malaria: A Phase I/IIa Dose-Escalation Safety Study


Sponsor

Douglas Postels, MD, MS

Enrollment

152 participants

Start Date

Aug 16, 2022

Study Type

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

Min Age: 12 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 6-diazo-5-oxo-L-norleucine (DON), a drug called 6-diazo-5-oxo-L-norleucine (DON), and others for people with malaria, cerebral. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG6-diazo-5-oxo-L-norleucine (DON)

Single intravenous dose ranging from 0.1-10 mg/kg per dose

DRUGPlacebo

Single intravenous dose of saline

DRUG6-diazo-5-oxo-L-norleucine (DON)

Single intravenous dose ranging from 0.1-1.0 mg/kg per dose


Locations(2)

Ndirande Research Clinic

Blantyre, Malawi

Queen Elizabeth Central Hospital

Blantyre, Malawi

View Full Details on ClinicalTrials.gov

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NCT05478720