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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT03726593
Eligibility Criteria:
Inclusion Criteria:
* Understands Khmer spoken language
* Male or female (18 to 70 years old)
* Microscopic confirmation of asexual stages of Pf or mixed infection with Pf, with baseline asexual parasite densities between 100/µL to 200,000/µL
* Able to take oral medications
* Hemoglobin on day of enrollment ≥9.0 g/dL
* Agree to follow-up for the anticipated study duration, including a minimum of 3 nights at the medical treatment facility (inpatient hospitalization) and weekly follow-up visits for at least 6 weeks
* If the volunteer is on active duty in the military, the volunteer has written permission from their supervisor or states to have been authorized by his/her supervisor or the local commander to participate; and allow study staff to contact their supervisor to confirm this information
Exclusion Criteria:
* Known allergic reaction to any of the study drugs or history of severe intolerance to any of the antimalarials used in this study.
* Pregnant or lactating females and females of childbearing potential who do not agree to use an acceptable form of contraception during the study period and for 6 weeks following the last dose of the study drug.
* Symptoms of severe vomiting (inability to tolerate oral fluids or oral medications during the previous 8 hours or vomiting \>3 times in the last 24 hrs).
* Diagnosis of severe malaria
* Abnormal liver function tests i.e AST or ALT or total bilirubin \> 1.5 upper limit of normal (ULN) with nausea AND right upper quadrant abdominal pain OR jaundice on exam
* Isolated AST or ALT or Total Bilirubin \>2x ULN
* Known significant cardiovascular, liver or renal abnormality or any other clinically significant illness, which in the opinion of the investigator would place the volunteer at significantly higher risk
* Treatment for malaria within the last 4 weeks
* Unable to provide informed consent
* Judged by the investigator to be otherwise unsuitable for study participation (to include, but not limited to, taking other medications that are known to cause serious drug-drug interactions with the study drugs, as determined by the study physician, or having suspected medical condition or taking other drugs that may affect test results interpretation or put the volunteer at much higher risk)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03726593
Study Brief:
Protocol Section:
NCT03726593