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 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT01899820
Eligibility Criteria:
Inclusion Criteria:
1. Age between 6 months - 5 years (in high endemic areas); 6 months to 10 years (in low endemic areas) inclusive.
2. Presence of axillary temperature \> 37.5oC or rectal / tympanic temp \> 38.0oC, or history of fever in the last 24 hours.
3. Monoinfection with Plasmodium falciparum with parasitaemia, asexual parasitemia between 2,000 - 200,000 p/µl (in areas of high transmission); 1,000-100,000p/ µl (in areas of low to moderate malaria transmission)
4. Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
5. Signed informed consent form by the parents or legal guardian.
Exclusion Criteria:
1. Presence of clinical danger signs: not able to drink or breast-feed, vomiting (\>twice in 24 hours), recent history of convulsions (\>1 in 24h), unconscious state, unable to sit or stand;
2. Mixed or mono-infection with another Plasmodium species detected by microscopy;
3. Presence of co-morbid infection (e.g. acute lower respiratory tract infection, severe diarrhoea with dehydration, Severe Anaemia) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases,Epilepsy, HIV/AIDS);
4. History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
10 Years
Study:
NCT01899820
Study Brief:
Protocol Section:
NCT01899820