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 @ 2:51 PM
Ignite Modification Date:
2025-12-24 @ 2:51 PM
NCT ID:
NCT00157859
Eligibility Criteria:
Inclusion Criteria:
-Male and female patients at least one 1year of age and weighing more than 10kg.
* -Microscopic confirmation of P. falciparum and /or P.vivax infection (any parasitaemia).
* -Fever (axillary temperature \>37.5oC) or history of fever in the last 48 hours.
* -Able to participate in the trial and comply with the clinical trial protocol
* -Written informed consent to participate in trial; verbal consent in presence of literate witness is required for illiterate patients, and written consent from parents/guardian for children below age of consent
Exclusion Criteria:
* Pregnancy or lactation
* -Inability to tolerate oral treatment
* -Signs/symptoms indicative of severe/complicated malaria or warning signs requiring parenteral treatment
* -Known hypersensitivity or allergy to artemisinin derivatives
* -Serious underlying disease (cardiac, renal or hepatic)
* -Parasitaemia \>4%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Study:
NCT00157859
Study Brief:
Protocol Section:
NCT00157859