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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT02092766
Eligibility Criteria:
Inclusion Criteria:
* Age \> 6 months and ≤ 14 years
* Acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum or mixed with non-falciparum species
* Asexual P. falciparum parasitaemia ≥ 100,000/uL and ≤500,000/uL
* Haemoglobin ≥5.0 g/dL
* Parents/guardians agree to hospitalize the child for the length of treatment (3 days) and bring the patient for planned follow-up visits at day 7, 14, 21, 28, 35, 42
* Signed consent from the guardian/parents
Exclusion Criteria:
* Body weight ≤ 5 kg
* Severe malaria or signs of severe malaria as defined by WHO Guidelines 2013
* History of hypersensitivity or contraindication to quinine or artesunate
* A clear history of adequate antimalarial treatment in the preceding 24 hours with drugs expected to be effective
* Presence of intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the patient treatment or results of the study
* Participation in another clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
14 Years
Study:
NCT02092766
Study Brief:
Protocol Section:
NCT02092766