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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT03640403
Eligibility Criteria:
Inclusion Criteria:
* Includes parental/guardian informed consent
* Assent by primary school children aged 11 years and above.
* Aged 5-15 years.
* Currently, lives within the pre-defined catchment area of Muheza District.
* Will remain within the same area throughout the study period (preferably class five and below).
Exclusion Criteria:
* Students at class 6 and 7
* Currently enrolled in another study or participated in another investigational drug study within the last 30 days.
* Known to have heart disease or a known cardiac ailment.
* Reports known hypersensitivity to the study drugs.
* Not willing to undergo all study procedures including physical examination and to provide blood samples as per this study protocol.
* Having clinical features of severe anaemia
* Febrile due to non-malaria illness at the time of recruitment.
* Has apparent severe infection or any condition that requires hospitalization
* Illness or conditions like hematologic, cardiac, renal, hepatic diseases which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study, including known G6PD deficiency and SS sickle cell.
* Body weight \< 14 k
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
15 Years
Study:
NCT03640403
Study Brief:
Protocol Section:
NCT03640403