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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT02353494
Eligibility Criteria:
Inclusion criteria:
* age between one year (weight more than 5 kgs) to 65 years old;
* mono-infection with Plasmodium falciparum or Plasmodium vivax detected by microscopy;
* parasitaemia of more than 1000/μl asexual parasites for P. falciparum and more than 250/μl asexual parasites for P. vivax
* presence of axillary temperature ≥ 37.5 °C or history of fever during the past 24 h;
* ability to swallow oral medication;
* ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
* informed consent from the patient or from a parent or guardian in the case of children.
Exclusion criteria:
* presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO
* mixed or mono-infection with another Plasmodium species detected by microscopy;
* 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);
* 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 dihydroartemisinin-piperaquine
* a positive pregnancy test or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
65 Years
Study:
NCT02353494
Study Brief:
Protocol Section:
NCT02353494