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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT02614404
Eligibility Criteria:
Inclusion Criteria:
* Gender: only adults are selected for the trial; note that female subjects cannot be women of child-bearing age.
* Age: 18-50 years.
* Target disease: Uncomplicated Plasmodium falciparum malaria
Exclusion Criteria:
* symptoms and signs of complicated malaria
* including continuous high fever of over 390C, psychiatric disorders, confusion, other neurological symptoms, symptoms and signs of functional impairment of the organs such as lungs, kidneys or cardiovascular system;
* symptoms and signs of liver damage or kidney damage
* symptoms and signs of another complicating infection such as pneumonia, dengue fever, and other bacterial infection.
* P. falciparum \> 25.000 / mm3
* WBC \<4000 and \>10.000 /mm3
* RBC \< 3.5x106/mm3
* Platelets \< 40.000 /mm3
* Hemoglobin \< 10 g/dL
* ALT more than 200% of the upper limit (56 units/L)
* AST more than 200% of the upper limit (40 units/L)
* Blood creatine more than 75% of the upper limit (men: 1.2 mg/dL, women 1 mgdL)
* Serum total protein \< 6 g/L
* Glycemia \< 50 mg/dL\> 200 mg/dL
* Standard urine test Serious alterations
* Concomitant treatments
Antimalarial Drugs Anticoagulant therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02614404
Study Brief:
Protocol Section:
NCT02614404