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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT01716260
Eligibility Criteria:
Inclusion Criteria:
* \>12 months of age
* infection with P.vivax parasitaemia monoinfection
* presence of axillary temperature \>37.5 degrees or history of fever during the past 24 hours
* ability to swallow oral medication
* ability and willingness to comply with the study protocol for the duration of the study, including 12 months follow up
* informed consent from the patient/parent/guardian in the case of children
Exclusion Criteria:
* Presence of general danger signs in children aged under 5 years or signs of severe malaria according to the definitions of WHO
* Presence of severe malnutrition (defined as a child whose growth standard is below -3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference \< 110 mm);
* History of haemolysis or severe anaemia
* Acute anaemia \<7 mg/dL
* Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
* Regular medication, which may interfere with antimalarial pharmacokinetics
* History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s)
* a positive pregnancy test or lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Study:
NCT01716260
Study Brief:
Protocol Section:
NCT01716260