Actively Recruiting
DON in Pediatric Cerebral Malaria
Led by Douglas Postels, MD, MS · Updated on 2025-07-31
152
Participants Needed
2
Research Sites
171 weeks
Total Duration
On this page
Sponsors
D
Douglas Postels, MD, MS
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
DON in Pediatric Cerebral Malaria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years and older for healthy and uncomplicated malaria groups
- Children aged 12 months to 14 years with cerebral malaria
- Signed informed consent obtained from participant or guardian
- For healthy adults: temperature ≤ 37.5 °C, BMI 18.5-25 kg/m2, normal creatinine levels, hemoglobin ≥ 7 g/dL or hematocrit ≥ 20%, negative malaria blood smear
- For adults with uncomplicated malaria: temperature ≥ 38 °C or recent fever, positive malaria blood smear, hemoglobin ≥ 7 g/dL or hematocrit ≥ 20%, BMI 18.5-25 kg/m2, normal creatinine, Glasgow coma score of 15, respiratory rate ≤ 20 breaths/min, oxygen saturation ≥ 90% on room air
- For children with cerebral malaria: temperature ≥ 38 °C or recent fever, positive malaria blood smear, Blantyre coma score ≤ 2, no other cause for coma, hematocrit ≥ 18%, normal creatinine, AST < 280 IU/L, ALT < 195 IU/L, negative pregnancy test if applicable
You will not qualify if you...
- Pregnancy or lactation; persons of childbearing potential must have negative pregnancy tests
- Planning pregnancy or attempting to become pregnant
- Currently taking highly active antiretroviral therapy (HAART)
- Currently taking anti-tuberculosis medications
- Allergy to ondansetron
- For children with cerebral malaria: cloudy cerebrospinal fluid indicating possible bacterial infection
- Severe malnutrition defined as ≥ 2 standard deviations below mean weight for height or MUAC ≤ 12.5 cm
- Allergy to ondansetron or ceftriaxone
- Coma lasting longer than 72 hours
- Use of CYP3A4 inhibitors within 7 days before enrollment
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Ndirande Research Clinic
Blantyre, Malawi
Completed
2
Queen Elizabeth Central Hospital
Blantyre, Malawi
Actively Recruiting
Research Team
Y
Yamikani Chimalizeni, MD
CONTACT
A
Alice Liomba
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
13
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