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 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT01256658
Eligibility Criteria:
Inclusion:
* Subjects who were diagnosed as Asymptomatic Carrier (AC) by Rapid Diagnostic Test (RDT).
* Subjects who were diagnosed with a Symptomatic malaria episode, RDT-confirmed (SMRC)
Exclusion:
* Body weight \<5 kg.
* Hypersensitivity to artemether-lumefantrine or to any of the excipients of the tablets or dispersible tablets.
* Presence of severe malaria signs and symptoms
* First trimester of pregnancy.
* Family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.
* Taking drugs that are known to influence cardiac function and to prolong QTc interval, such as class IA and III: neuroleptics, antidepressant agents, certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole and triazole antifungal agents, certain non-sedating antihistamines.
* Known disturbances of electrolyte balance, e.g. hypokalemia or hypomagnesemia.
* Taking drugs which may be metabolized by cytochrome enzyme CYP2D6
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01256658
Study Brief:
Protocol Section:
NCT01256658