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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT02600767
Eligibility Criteria:
Inclusion Criteria:
* \>= 5 years
* body weight \< 120kg
* documented fever (axillary temperature ≥37.5o C) or history of fever in the previous 48 hours in the absence of other obvious causes of fever, such as pneumonia, middle ear infection, etc.
* monoinfection by P. falciparum with parasitemia between 250 and 200,000 asexual parasites/µl, as determined by swab and thick peripheral blood smear microscopic exam
* patient or parent/caregiver able to comprehend and sign informed consent or permission form
* patients aged 7-17 years able to provide assent, patients aged 5-6 years do not require assent
* willingness to return to the clinic and/or accept home visits for regular check-ups during the 28-day follow-up period
* hemoglobin level ≥8 g/dl
Exclusion Criteria
* presence of malaria danger signs (inability to drink, vomiting (more than twice in the previous 24 hours), recent history of seizures (one or more in the previous 24 hours), altered level of consciousness, inability to sit or stand up); presence of signs of severe malaria (altered level of consciousness, psychomotor alteration, seizure, torpor and irreversible coma), severe anemia (hematocrit \< 15% or clinical signs, hemoglobin \<5 g/dl), renal failure (serum creatinine \> 3 mg/dl or clinical signs), pulmonary edema, hypoglycemia (blood glucose \< 40 mg/dl or clinical signs), shock (systolic blood pressure \< 70 mmHg for adults; \< 50 mmHg for children), spontaneous hemorrhage/disseminated intravascular coagulation, repeated generalized seizures, acidemia/acidosis (clinical signs), macroscopic hemoglobinuria, and jaundice.
* history of chronic or severe underlying diseases (e.g. heart, renal or liver diseases, HIV/AIDS, tuberculosis, malnourishment)
* history of hypersensitivity to AL
* current pregnancy (history of current pregnancy or positive pregnancy test)
* use of any antimalarial drug in the previous 30 days.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Study:
NCT02600767
Study Brief:
Protocol Section:
NCT02600767