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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT02645604
Eligibility Criteria:
* INCLUSION CRITERIA:
Subject Inclusion Criteria: AL Resistance Monitoring Study
* Resident of Kenieroba
* Age 2 to 17 years
* Uncomplicated falciparum malaria, confirmed by the presence of asexual P. falciparum parasites on blood film
* Asexual P. falciparum count between 2,000 and 200,000/ microliters (inclusive) at screening
* Tympanic or axillary temperature greater than or equal to 37.5 (Infinite)C or history of fever in the previous 24 hours
* Written informed consent from the child s parent or guardian, and assent from children aged 14-17 years
Subject Inclusion Criteria: Parasite Clearance Substudy
* Enrolled in the AL Resistance Monitoring Study
* Asexual P. falciparum count greater than or equal to 10,000/ microliters at screening
* Hb level greater than or equal to 7 g/dL
Subject Inclusion Criteria: Blood Collection Study
* Age 18 to 65 years or 5 to 65 years old for the mosquito infectivity study
* Healthy-appearing
* Hb level greater than or equal to 7 g/dL
EXCLUSION CRITERIA:
Subject Exclusion Criteria: AL Efficacy Study
* Signs of severe malaria, defined as one or more of the following:
* Blantyre Coma Scale less than or equal to 3/5 in children
* Witnessed convulsions
* Severe prostration
* Shock (poor perfusion, cool peripheries)
* Hb \<5 g/dL
* Jaundice
* Respiratory distress (labored breathing, nasal flaring, intercostal retraction)
* Anuria for 24 hours or more
* Repetitive vomiting
* Cessation of eating and drinking
* Acute illness other than uncomplicated falciparum malaria requiring treatment
* Presence of P. ovale or P. malariae parasites on blood film
* Severe malnutrition: http://www.who.int/childgrowth/standards/Technical\_report.pdf
* Pregnancy or breastfeeding an infant
* Planning to become pregnant in the next 1 month
* History of taking an ACT in the previous 14 days
* Known hypersensitivity to artemether or LF
* Co-administration of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St. John s wort
* Splenectomy
* Any condition that in the opinion of the investigator would render the patient unable to comply with the protocol (e.g., psychiatric disease)
* Any health condition that in the opinion of the investigator would confound data analysis (e.g., HIV infection) or pose unnecessary exposure risks to the subject
Subject Exclusion Criteria: Parasite Clearance Substudy
-Prior enrollment in the Parasite Clearance Substudy in current transmission season
Subject Exclusion Criteria: Blood Collection Study
* P. falciparum infection, as determined by thick blood smear examination (unless the subject is being screened for inclusion in the mosquito infectivity study, in which case parasitemia, as detected by RDT or smear, is an inclusion criteria)
* History of taking an ACT in the previous 28 days
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
65 Years
Study:
NCT02645604
Study Brief:
Protocol Section:
NCT02645604