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:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-24 @ 12:17 PM
NCT ID:
NCT00454961
Eligibility Criteria:
Inclusion Criteria:
1. Aged \<5 years
2. Weight \>5 kg
3. Suffering from acute uncomplicated P. falciparum malaria confirmed by RDT. Later microscopy using Giemsa-stained thick film will be made to ensure asexual parasite density of 2000 to 200 000 parasites/µL
4. Having a history of fever in the preceding 24 h
5. Able to ingest tablets orally
6. Willing and able to attend stipulated follow-up visits
7. With written informed consent from parent/guardian for children to participate in the trial.
Exclusion Criteria:
Presenting with any of the following "danger signs of severe malaria":
1. Convulsions (\>1 episode within previous 24 hours)
2. Lethargic/unconscious
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
5 Years
Study:
NCT00454961
Study Brief:
Protocol Section:
NCT00454961