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 @ 2:01 PM
Ignite Modification Date:
2025-12-24 @ 2:01 PM
NCT ID:
NCT05951595
Eligibility Criteria:
Inclusion Criteria:
* Male or female, aged ≥6 months (no upper limit unless one is required by local regulations) and bodyweight ≥5 kg
* Ability to take oral medication
* Fever defined as ≥38°C tympanic temperature or a history of fever within the last 24 hours
* Acute uncomplicated P. falciparum monoinfection
* Asexual P. falciparum parasitaemia: 1,000/µL to 250,000/µL determined on a peripheral blood film
* Written informed consent by the participant, or by the parent/guardian in case of children lower than the age of consent, and assent if required (per local regulations)
* Willingness and ability of the participants or parents/guardians to comply with the study protocol for the duration of the study
Exclusion Criteria:
* Signs of severe malaria (adapted from WHO criteria)
* Patients not fulfilling criteria for severe malaria but with other indication(s) for parenteral antimalarial treatment at the discretion of the treating physician
* Haemoglobin \<7 g/dL at screening
* Participants who have received artemisinin or a derivative within the previous 7 days OR lumefantrine or amodiaquine within the previous 14 days
* In applicable countries: use of seasonal malaria chemoprophylaxis (SMC) within the last 30 days
* Acute illness other than malaria requiring systemic treatment
* Severe acute malnutrition
* Known HIV, tuberculosis, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or other severe infection
* For women of child-bearing age: pregnant, trying to get pregnant or lactating
* History of allergy or known contraindication to any of the study drugs, including neuropsychiatric disorders and epilepsy
* Previous splenectomy
* Participation in the previous 3 months and/or ongoing follow-up for an interventional study (including FD-TACT)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Study:
NCT05951595
Study Brief:
Protocol Section:
NCT05951595