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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT05070520
Eligibility Criteria:
Inclusion Criteria:
* Brachial circumference (BC) \> 125 mm and P/T z-score \> -2 Standard Deviation (SD)
* Age between three months and fifteen years,
* Monospecific Plasmodium falciparum infestation detected by microscopy;
* Parasitemia between 1000 and 200000 asexual parasitic forms/µl ;
* Axillary temperature ≥37.5° or history of fever in the past 24 hours ;
* Ability to take oral medications;
* Ability and willingness to adhere to the protocol for the duration of the study and to adhere to the visit schedule ;
* Informed consent of the accompanying person (guardian or parent).
Exclusion Criteria:
* Inability to take oral medications
* History of antimalarial treatment in the past two weeks, including sulfadoxine-pyrimethamine (SPAQ) for seasonal malaria chemoprevention (SMC)
* Lack of consent for pregnancy testing
* Presence of general danger signs in children under five years of age or signs of severe P. falciparum malaria as defined by World Health Organization (WHO);
* Mixed infestation or monospecific infestation with another Plasmodium species, detected by microscopic examination;
* Severe malnutrition defined by a BC \<125 mm AND P/T z-score \< -3 Standard Deviation (SD)
* Moderate malnutrition defined by a BC \<125 mm AND a -3 ≤P/T z-score \< -2 SD
* Febrile condition due to illnesses other than malaria (e.g., measles, acute lower respiratory tract infection, severe diarrheal illness with dehydration) or other known chronic or severe underlying illnesses (e.g., cardiac, renal, or liver disease, HIV/AIDS) ;
* Regular use of medications that may interfere with antimalarial pharmacokinetics;
* History of hypersensitivity or contraindication to any of the drugs tested or used as replacement therapy;
* Lack of informed consent from the patient or accompanying person
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
15 Years
Study:
NCT05070520
Study Brief:
Protocol Section:
NCT05070520