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 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT06806956
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria for severe malaria
* From a village without other research interventions
* Children aged from 6 months to ≤5 years that present at the health system and are either; with fever (or history of fever within 2 days) and have a positive mRDT test plus at least one of the following danger signs for malaria (as per standardized national iCCM guidelines):
* convulsions
* inability to drink, eat, or suck
* vomiting all liquids and solids
* altered consciousness/coma
* lethargy
* chest in-drawing Inclusion for uncomplicated malaria
* Children aged from 6 months to ≤5 years; with fever (or history of fever within 2 days) with no danger signs for malaria (as per the standardized national Integrated Management of Childhood Illnesses guidelines) with a positive mRDT for Plasmodium falciparum histidine-rich protein.
Inclusion for severe non-malaria
* From a village without other research interventions
* Children aged from 6 months to ≤5 years that present at the health system and are either; with fever (or history of fever within 2 days) and have a negative mRDT test plus at least one of the following danger signs as per standardized national iCCM guidelines:
* convulsions
* inability to drink, eat, or suck
* vomiting all liquids and solids
* altered consciousness/coma
* lethargy
* chest in-drawing
* For participants in sentinel sites, a written informed consent will be provided by the patient's parent or guardian to take filter paper blood samples and to participate in interviews (questionnaires and IDI) at enrolment, day 14 and day 28 (to assess malaria recurrence and look for markers of resistance). If the parent or guardian is unable to write, thumb print witnessed consent is permitted. The informed consent shall be administered by the CHWs. Willingness and ability of the patient and the parent or guardian to comply with the treatment policy.
Exclusion Criteria:
* Use of any investigational or non-registered product or planned use during the study period.
* Participation in other studies within 30 days before the current study begins and/or during study participation.
* Inability to comprehend and/or unwillingness to follow the study protocol.
* For RAS use: if the child has reacted badly to artesunate in the past (in sites where RAS is administered)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
5 Years
Study:
NCT06806956
Study Brief:
Protocol Section:
NCT06806956