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 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT03916003
Eligibility Criteria:
Inclusion Criteria:
* P. falciparum mono-infection
* Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours
* Age \>1 years (≥ 18 years at the Ethiopia site)
* G6PD normal as defined by the Biosensor (SD Biosensor, ROK) at ≥70% of the adjusted male median (AMM) for each site
* Written informed consent
* Able to comply with all study procedures and timelines
Exclusion Criteria:
* General danger signs or symptoms of severe malaria
* Anaemia, defined as Hb \<8g/dl
* Pregnant women as determined by Urine β-HCG pregnancy test
* Breast feeding women
* Known hypersensitivity to any of the drugs given
* Regular use of drugs with haemolytic potential
* Blood transfusion within the last 4 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Study:
NCT03916003
Study Brief:
Protocol Section:
NCT03916003