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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT00936767
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 16 years
* Full written informed consent is obtained
* Willingness and ability to comply with the study protocol for the duration of the trial including agreement to 5 days hospitalisation.
* History of fever or presence of fever (tympanic or axillary temperature at \>37.5 °C).
* Peripheral blood P.falciparum parasitaemia between 10,000/uL and 200,000/uL. (Mixed malaria infection included)
Exclusion Criteria:
* Known hypersensitivity to the study drugs.
* Any antimalarial drug treatment in the 48 hours prior to enrolment.
* Clinical and/or laboratory features of severe malaria (as defined by WHO).
* Gastrointestinal dysfunction that could alter absorption or motility (i.e. active peptic ulcer, inflammatory bowel disease, malabsorption syndromes, intestinal sub-occlusion or previous major gastrointestinal surgery).
* Presence of intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.
* Splenectomy.
* Pregnant or lactating women. Serum test for β-HCG to be performed on any woman of child bearing age unless menstruating.
* Taking any contraindicated medicines (as listed in the most up to date product information)
* Participation in a clinical study within the previous 12 weeks
* Any other condition in the opinion of the investigator makes the patient unsuitable to be a subject
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00936767
Study Brief:
Protocol Section:
NCT00936767