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 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 1:15 AM
NCT ID:
NCT05958693
Eligibility Criteria:
Inclusion Criteria:
* Above 6 months old to 59 years old;
* Mono-infection with P. falciparum (1000-100 000 asexual forms per µl)
* Axillary temperature ≥37.5 °C or oral/rectal temperature of ≥38 °C;
* Ability to swallow medication;
* Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
* Informed consent from the patient or from a parent or legal guardian in the case of children less than 18 years old;
* Informed assent from any minor participant aged 12 - 17 years; and
* Consent for pregnancy testing from females of child-bearing potential and from their parent or guardian if under 18 years old.
Exclusion Criteria:
* Presence of general danger signs among children \<5 years old or other signs of severe and complicated falciparum malaria according to current WHO definitions
* Mixed Plasmodium species;
* Presence of severe malnutrition
* Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhea with dehydration, etc.), or other known underlying chronic or severe diseases (e.g. cardiac, renal, hepatic diseases, HIV/AIDS)
* History of hypersensitivity reactions to any of the drug(s) being tested or used as an alternative treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
59 Years
Study:
NCT05958693
Study Brief:
Protocol Section:
NCT05958693