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 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT01958905
Eligibility Criteria:
Inclusion Criteria:
* Age between 6 and 59 months
* Weight ≥ 5 kg
* P. falciparum monoinfection confirmed on a thick blood film
* Parasitic density between 1,000 and 200,000 asexual forms/µL of blood.
* Measured axillary temperature ≥ 37.5 ° C or history of fever during the previous 24 hours
* High probability of compliance with follow-up visits (no near-term travel plans)
* Consent of a parent or guardian who is at least 18 years of age.
* According to the group: in severely malnourished, weight-for-height z-score \<-3 SD or MUAC \<115 mm, and in non-severely malnourished, weight-for-height z-score ≥- 3 standard deviations (SD), and MUAC≥ 115 mm.
Exclusion Criteria:
* General danger signs or signs of complicated malaria as defined by the WHO (Appendix 1)
* Mixed or mono-infection with another Plasmodium species detected by microscopy
* Severe anemia (hemoglobin \<5 g / dL)
* Known underlying chronic or severe disease (e.g. cardiac, renal or hepatic disease, tuberculosis, sickle cell)
* Known HIV/AIDS infection
* Known history of hypersensitivity or contra-indication to any of the study medications: artemether, lumefantrine (first-line medications), or artesunate, amodiaquine (rescue medications)
* Presence of febrile conditions due to diseases other than malaria which could alter the outcome of the study
* History of a full treatment course with AL in the past 14 days.
* Height-for-age \<-3 Z scores
* Severe complications of malnutrition requiring hospitalization in intensive care or stabilization: Severe signs of kwashiorkor, Anorexia (failure to the appetite test), Hyperemesis, Severe acute infection, Hypothermia \<35 ˚ C (axillary) or hypoglycemia, Diarrhea with dehydration, Lethargy, coma, Clinical signs of vitamin A deficiency (xerophthalmia)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
5 Years
Study:
NCT01958905
Study Brief:
Protocol Section:
NCT01958905