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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT00694694
Eligibility Criteria:
Inclusion Criteria:
Children with symptoms suggestive of malaria and
1. P.falciparum of at least 2000 parasites per microL of blood
2. are able to take study drugs by the oral route
3. are able to attend stipulated days for follow up clinic and provide specimens
4. have a parent or guardian who can give informed written/verbal consent to participate in the study
5. aged 6-59 months.
Exclusion Criteria:
1. severe and complicated forms of malaria (WHO, 2000)
2. a mixed plasmodial infection
3. a concomitant disease masking assessment of the treatment response (cases in whom advanced HIV infection is suspected will lead to be referred for HIV counseling).
4. recent effective full dose antimalarial treatment (within 7 days), excluding chloroquine, SP and AQ which have \>70% failure in this district, or combinations of these.
5. known hypersensitivity to any of the trial drugs.
6. live too far away for reliable follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
5 Years
Study:
NCT00694694
Study Brief:
Protocol Section:
NCT00694694