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:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-24 @ 4:05 PM
NCT ID:
NCT02659566
Eligibility Criteria:
* INCLUSION CRITERIA:
A study participant must satisfy the following criteria to be enrolled in this study:
* Provide individual informed consent
* Adult between ages of 18 and 60
* Willingness to have blood samples stored for future research
* Known resident of Ouelessebougou or surrounding area
EXCLUSION CRITERIA:
A subject will be excluded from participating in this trial if any one of the following criteria is fulfilled:
* Known to be pregnant (by history) or positive pregnancy test
* Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, psychiatric, or renal disease by history and/or physical examination that may impact the subject s overall health and immune system
* Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol
* Use of chronic (greater than or equal to14 days) oral or intravenous corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone \>10 mg/day) or immunosuppressive drugs within 30 days of Study Day 0
* Receipt of Coartem within less than 14 days from Study Day 0
* Known allergies or contraindications (such as significant cardiac disease prolonged QTc \>450 ms; currently taking medications that may prolong your QTc; serious side effects from Coartem in the past) to study treatment (Coartem \[artemether/lumefantrine\])
* Receipt of investigational malaria vaccine within the last 5 years
* Enrollment in another investigational trial during the study period (participating in screening for other investigational trials is permitted)
* Tested positive for HIV or Hepatitis B or Hepatitis C.
* Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial, interfere with the evaluation of the study objectives, or would render the subject unable to comply with the protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02659566
Study Brief:
Protocol Section:
NCT02659566