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:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-26 @ 2:38 PM
NCT ID:
NCT01680406
Eligibility Criteria:
Inclusion Criteria:
* Slide-confirmed infection with P. vivax
* Age \> 1 year
* Lives within 20 km of the enrolling health facility
* Weight ≥ 5.0 kg
* Axillary temperature ≥ 37.5º C or history of fever during the previous 48 hours
* Patient or caregiver agrees to all finger pricks and return visits.
Exclusion Criteria:
* General danger signs or symptoms of severe malaria (see Annex II)
* Signs or symptoms of severe malnutrition, defined as weight-for-age ≤ 3 standard deviations below the mean (NCHS/WHO normalized reference values)
* Slide confirmed infection with any other Plasmodium species. besides P. vivax mono-infection
* Acute anemia, defined as Hg \< 8 g/dl
* Known hypersensitivity to any of the drugs being evaluated
* Presence of febrile conditions caused by diseases other than malaria
* Serious or chronic medical condition by history (cardiac, renal, hepatic diseases, sickle cell disease, HIV/AIDS)
* Pregnant or breastfeeding women.
* History or hemolysis or severe anemia
* Regular medication, which may interfere with antimalarial pharmacokinetics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Study:
NCT01680406
Study Brief:
Protocol Section:
NCT01680406