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 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
NCT ID:
NCT05878366
Eligibility Criteria:
The study population will be derived from individuals aged 3 months to up to 10 years old eligible for SMC.
Inclusion criteria:
* Eligible for chemoprevention for SMC as per the current recommendations
* Age 3- 59 months for arms i. and ii.
* Age 60 months up to 10 years old for arm iii.
* Absence of symptomatic falciparum malaria, defined by fever on enrolment
* Absence of other non-P. falciparum species on blood film
* No evidence of acute severe or chronic disease
* Able and willing to comply with the study protocol and follow-up schedule
* Parent or guardian provides written, informed consent on behalf of child
Exclusion criteria:
* Symptoms of malaria (axillary fever ≥ 37.5 °C and/or history of fever in the past 48 hours)
* Previous reaction to study drugs / known allergy to study drugs
* Signs of severe malaria, including hyperparasitemia (defined as asexual parasitemia \> 100,000 parasites / µL)
* Signs of acute or chronic illness, including hepatitis
* The use of other medication (except for paracetamol and/or aspirin)
* Presence of severe malnutrition according to WHO's child growth standards
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Months
Study:
NCT05878366
Study Brief:
Protocol Section:
NCT05878366