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 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT01082705
Eligibility Criteria:
Inclusion Criteria:
1. Age 6-59 months
2. Axillary temperature ≥ 37.5º C or history of fever in the past 48 hours
3. Weight ≥ 5.0 kg
4. Slide-confirmed infection with P. falciparum, with parasitemia 2,000-200,000 asexual forms per μl
5. Live within the boundaries of the officially recognized catchment area of Miono Health Center.
6. Caregiver agrees to all blood draws and return visits.
Exclusion Criteria:
1. General danger signs or symptoms of severe malaria
2. Signs or symptoms of severe malnutrition, defined as weight-for-age ≤ 3 standard deviations below the mean (National Center for Health Statistics \[NCHS\]/World Health Organization \[WHO\] normalized reference values)
3. Slide confirmed infection with any other Plasmodium spp. besides falciparum or mixed plasmodium infection
4. Severe anemia, defined as Hb \< 5 g/dl
5. Known hypersensitivity to any of the drugs being tested
6. Presence of febrile conditions caused by diseases other than malaria
7. Serious or chronic medical condition (heart failure, sickle cell disease).
8. Plan to travel or leave the area within the next 3 months.
9. Have been treated for malaria in the 2 weeks prior to enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
59 Months
Study:
NCT01082705
Study Brief:
Protocol Section:
NCT01082705