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 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT01361269
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects aged three to ten years
* Body weight ≥12kg
* Acute (symptoms lasting less than 14 days) uncomplicated P falciparum malaria
* Asexual parasitaemia between 1,000/µL and 200,000/µL
* Ability to tolerate oral therapy
* Willingness of the parent or guardian to provide informed signed consent
Exclusion Criteria:
* Symptoms/signs of severe malaria, according to WHO criteria (see appendix I)
* Body weight \<12kg
* Other concomitant plasmodial infections (P vivax, P ovale, P malariae)
* Severe malnutrition with weight for height \<70% (according to WHO tables) or clinical kwashiorkor
* Gastro-intestinal disturbance with persistent vomiting (\> three episodes within previous 24 hours) and/or diarrhoea (\> 5 loose stools in the preceding 24 hours)
* Concomitant disease masking assessment of response including sickle cell disease and severe cardiac, hepatic or renal impairment
* Packed cell volume (PCV) on arrival \<22%
* Adequate anti-malarial treatment within previous 7 days
* Inability to tolerate oral therapy
* Parent or guardian deemed to be unsupportive
* On co-trimoxazole prophylaxis
* Any known allergies to the investigational products
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
10 Years
Study:
NCT01361269
Study Brief:
Protocol Section:
NCT01361269