Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT05478720
Eligibility Criteria:
Inclusion Criteria:
For Healthy Adults (Arm 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 (Arm 2):
* 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 (Arm 3):
* 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
Additional Exclusion Criteria for Children with Cerebral Malaria (Arm 3):
* Cloudy cerebrospinal fluid (indicative of a probable bacterial central nervous system infection)
* Malnutrition defined as a more than or equal to two standard deviations below the mean weight for height and/ or MUAC ≤ 12.5 cm (due to inability to adequately care for children with severe malnutrition on the PRW)
* Allergy to ondansetron or ceftriaxone
* Coma for \> 72 hours
* Have taken a CYP3A4 inhibitor within 7 days of enrollment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Study:
NCT05478720
Study Brief:
Protocol Section:
NCT05478720