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 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT01755559
Eligibility Criteria:
Inclusion Criteria:
* Age between 6 and 59 months
* Weight ≥ 5 kg
* Mono-infection with P. falciparum detected by microscopy
* Parasitic density between 2,000 and 200,000 asexual forms /µL of blood
* Axillary temperature ≥ 37.5°C or history of fever during the previous 24 hours
* Ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule (home is within one hour of walk from the outpatient department, no near-term travel plans, etc.)
* Consent of a parent or guardian who is at least 18 years of age.
Exclusion Criteria:
* Presence of general danger signs as defined by the WHO,
* Presence of signs of severe malaria according to the definitions of WHO,
* Severe anemia (haemoglobin \<5 g/dL),
* Known history of symptomatic cardiac arrhythmias or with clinically relevant bradycardia,
* Family history of sudden death or of congenital prolongation of corrected QT interval,
* Use of antiarrhythmics or neuroleptics,
* Known history of hypersensitivity to any of the study medications,
* Severe malnutrition (defined as a weight-height ratio of \< -3 z-score according to the 2006 WHO reference (20) and / or a mid-upper arm circumference lower than 115 mm and / or the presence of symmetrical oedema of the feet),
* Presence of a febrile condition due to a disease other than malaria (i.e. measles, acute lower respiratory tract infection, otitis media, tonsillitis, abscess, severe diarrhoea with dehydration, etc.)
* History of a full treatment course with one of the three study drugs in the past 28 days. The prior incomplete intake of one of the three study drugs or prior intake of antimalarial drugs not being tested in the study does not exclude a patient from participating in this study. However, information on these previous treatments will be carefully recorded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
59 Months
Study:
NCT01755559
Study Brief:
Protocol Section:
NCT01755559