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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT01350856
Eligibility Criteria:
Inclusion Criteria:
* Male or female, aged from 6 months to 65 years old, inclusive
* Acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum (or mixed with non-falciparum species)
* Asexual P. falciparum parasitaemia: 10,000 to 200,000/uL, determined on a thin or thick blood film
* Fever defined as \> 37.5°C tympanic temperature or a history of fever within the last 24 hours
* Written informed consent (by legally acceptable representative in case of children)
* Willingness and ability of the patients/guardians to comply with the study protocol for the duration of the study
Exclusion Criteria:
* Signs of severe/complicated malaria (WHO, 2000)
* Haematocrit \< 25% or haemoglobin (Hb) \< 8 g/dL at enrollment
* Acute illness other than malaria requiring treatment
* For females: pregnancy, breast feeding
* Patients who have received artemisinin or a derivative or an artemisinin-containing combination therapy (ACT) within the previous 7 days
* History of allergy or known contraindication to artemisinins, or to the ACT to be used at the site
* Previous splenectomy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
65 Years
Study:
NCT01350856
Study Brief:
Protocol Section:
NCT01350856