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 @ 3:16 AM
Ignite Modification Date:
2025-12-25 @ 3:16 AM
NCT ID:
NCT06044805
Eligibility Criteria:
Inclusion Criteria:
* Age \> 6 months
* Slide confirmed infection with P. vivax with \> 250 asexual forms/μl
* Lives within 5 km of the enrolling health facility
* Weight ≥ 5.0 kg
* Ability to swallow oral medication
* Ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule
* Informed consent from patient or from a parent or guardian in the case of children
Exclusion Criteria:
* Sever malaria with complication sign and symptoms
* Signs or symptoms of severe malnutrition, defined as weight-for-age ≤ 3 standard deviations below the mean, symmetrical edema involving at least the feet, or mid-upper arm circumference \<100 cm for children less than five years of age
* Mixed plasmodium infection
* Severe anemia, defined as hemoglobin (Hb) \< 5 g/dl
* Presence of febrile conditions caused by diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration)
* Serious or chronic medical condition (e.g. cardiac, renal, hepatic diseases, sickle cell disease, HIV/AIDS)
* Positive pregnancy test or breastfeeding
* Unable or unwilling to take contraceptives for women of child-bearing age
* Children weighing less than 5 kilograms
* History of hypersensitivity reaction to any medication tested or used as an alternative treatment
* Participants with history of prolonged QT conditions
* Taking regular medication, which may interfere with antimalarial pharmacokinetics or efficacy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Study:
NCT06044805
Study Brief:
Protocol Section:
NCT06044805