Experimental drug DON aims to protect brains of children with cerebral malaria

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: For Healthy Adults (Part 1): * 18 years and older * Informed consent obtained and ICF signed * Temperature ≤ 37.5 °C * BMI 18.5-25 kg/m2 * Creatinine ≤ 110 mmol/L (≤ 1.2 mg/dL; males) or ≤ 90 mmol/L (≤ 1.0 mg/dL; females) * Hemoglobin ≥ 7 g/dL or hematocrit/ packed-cell volume (PCV) ≥ 20% * Thick or thin blood smear negative for asexual forms of P. falciparum * Negative pregnancy test for persons of child-bearing potential For Adults with Uncomplicated Malaria (Part 1): * 18 years and older * Informed consent obtained and ICF signed * Temperature ≥ 38 °C or history of fever in the past 24 hours * Thick or thin blood smear positive for asexual forms of P. falciparum (parasite count and speciation documented) * Hemoglobin ≥ 7 g/dL or hematocrit/ PCV ≥ 20% * BMI 18.5-25 kg/m2 * Creatinine ≤ 110 mmol/L (≤ 1.2 mg/dL; males) or ≤ 90 mmol/L (≤ 1.0 mg/dL; females) * Glasgow coma score of 15 * Respiratory rate ≤ 20 breaths/ minute * Oxygen saturation ≥ 90% on room air * Negative pregnancy test for person of child-bearing potential For Children with Cerebral Malaria (Part 2): * Age 12 months-14 years old * Informed consent obtained and ICF signed by parent or guardian * Temperature ≥ 38 °C or history of fever in the last 24 hours * Thick or thin blood smear positive for asexual forms of P. falciparum * Blantyre coma score ≤ 2 * No other explanation for coma by history or physical exam * Hematocrit or PCV ≥ 18% * Negative pregnancy test for persons of child-bearing potential * Creatinine ≤ 1.5 mg/dL * Aspartate aminotransferase (AST) \< 280 IU/L * Alanine aminotransferase (ALT) \< 195 IU/L Exclusion Criteria (All Participants): * Pregnancy or lactation (participants of child-bearing potential ages 9-59 years will undergo pregnancy testing prior to administration of the intervention) * Participants attempting to become pregnant * Currently taking highly active antiretroviral therapy (HAART) * Currently taking anti-tuberculosis medications * Allergy to ondansetron or ceftriaxone Additional Exclusion Criteria for Children with Cerebral Malaria (Part 2): * Cloudy cerebrospinal fluid (indicative of a probable bacterial central nervous system infection) * Severe malnutrition (\>3 standard deviations below the mean weight for height and/ or mid-upper arm circumference (MUAC) ≤11.5 cm * Allergy to ondansetron or ceftriaxone * Coma for \> 72 hours * Have taken a CYP3A4 inhibitor within 7 days of enrollment