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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT01603251
Eligibility Criteria:
Inclusion Criteria:
* asymptomatically infected individuals with any P. falciparum parasite density
Exclusion Criteria:
* age \< 15 years or \> 25 years
* malaria parasite density ≥ 10,000 parasites/µL
* clinical symptoms indicating severe malaria
* axillary temperature ≥ 37.5°C
* Body Mass Index (BMI) below 18 or above 32 kg/m2
* haemoglobin concentration below 11 g/dL
* taken ivermectin in the last three months
* Loa loa as assessed by questionnaire, clinical examination and parasitological assessments
* for women: pregnancy or lactation
* known hypersensitivity to AL or IVM
* history and/or symptoms indicating chronic illness
* current use of tuberculosis or anti-retroviral medication
* unable to give written informed consent
* unwillingness to participate in two membrane feeding assays
* travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan. If a potential participant has ever visited one or more of these countries, he or she will not be eligible for enrolment.
* history of cardiovascular 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 antihistaminics (terfenadine, astemizole) and cisapride.
* known disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia.
* taking drugs which may be metabolized by cytochrome enzyme CYP2D6 (e.g., flecainide, metoprolol, imipramine, amitriptyline, clomipramine).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
25 Years
Study:
NCT01603251
Study Brief:
Protocol Section:
NCT01603251