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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT05306067
Eligibility Criteria:
A) LOW TRANSMISSION AREAS
Inclusion Criteria:
* Any age
* Fever (axillary temperature ≥37.5ºC) or history of fever in the preceding 24 hours
* Positive parasitological test for malaria diagnosis via RDT or microscopy OR
* Household contact of someone with fever/history of fever and Pf positive RDT
* Positive parasitological test for malaria diagnosis via RDT OR
* Pregnant women attending first antenatal care visit AND
* Informed, written consent to participate from participant and/or guardian
Exclusion Criteria:
* Any symptoms of severe malaria
* Negative parasitological test for malaria via RDT or microscopy (except any women at their first ANC visit, who will be recruited before testing for malaria with an RDT)
* Unwilling to provide informed, written consent
* History of antimalarial treatment in the last 14 days
B) MEDIUM-TO-HIGH TRANSMISSION AREAS
Inclusion Criteria:
* Children 2-10 years of age
* Fever (axillary temperature ≥37.5ºC) or history of fever in the preceding 24 hours
* Positive parasitological test for malaria diagnosis via RDT or microscopy OR
* Pregnant women attending first antenatal care visit AND
* Informed, written consent to participate from participant and/or guardian
Exclusion Criteria:
* Any symptoms of severe malaria
* Negative parasitological test for malaria via RDT or microscopy (except any women at their first ANC visit, who will be recruited before testing for malaria with an RDT)
* Unwilling to provide informed, written consent
* History of antimalarial treatment in the last 14 days
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Study:
NCT05306067
Study Brief:
Protocol Section:
NCT05306067