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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT00522132
Eligibility Criteria:
Inclusion Criteria:
* Male or female children aged 6 months and ≥ 5kg to 10 years, inclusive.
* Clinical diagnosis of severe P. falciparum malaria (see Appendix B) requiring hospitalization.
* Parasitemia (more than 5,000 parasites/microL on initial blood smear).
* Availability of child's parent/guardian and their willingness to provide written informed consent in accordance to local practice.
* Willingness and ability to comply with the study protocol for the duration of the study.
* Willingness to remain in the hospital for 4 days
Exclusion Criteria:
* Known serious adverse reaction or hypersensitivity to artemisinins, including artesunate, artemether, dihydroartemisinins or Co-Artem (artemether/lumefantrine).
* Any underlying disease that may compromise the diagnosis and the evaluation of the response to the study medication (including concomitant infection, concomitant neurological disease and malnutrition)
* Participation in any investigational drug study during the 30 days prior to Screening.
* Adequate anti-malarial treatment within 24 hours prior to admission.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
10 Years
Study:
NCT00522132
Study Brief:
Protocol Section:
NCT00522132