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 @ 4:03 PM
Ignite Modification Date:
2025-12-24 @ 4:03 PM
NCT ID:
NCT02604966
Eligibility Criteria:
Inclusion Criteria:
* Mono-infection with P. falciparum;
* Parasite density (trophozoites) between 500-100,000/µl;
* Fever (axillary temperature 37.5C) or history of fever in the previous 24h.;
* Ability to swallow oral medication;
* Ability and willingness to comply with the study protocol and with the study visit schedule;
* Written informed consent/assent to participate to the trial.
Exclusion Criteria:
* Mixed or mono-infection with another Plasmodium species confirmed by microscopy;
* General danger signs or symptoms of severe malaria according to WHO definitions;
* Signs or symptoms of severe malnutrition (weight-for-age ≤ 3 standard deviations below the mean (NCHS/WHO normalized reference values));
* Anaemia (Hb \<7g/dl in adults (\<5g/dl in children));
* Pregnancy or lactation (urine test for β HCG);
* Concomitant acute illness necessitating specific treatment (antibiotics);
* Underlying chronic severe illness (e.g. cardiac, renal, hepatic diseases, HIV/AIDS);
* Known hypersensitivity to any of the drugs being evaluated;
* Regular use of medication that may interfere with antimalaria pharmacokinetics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Study:
NCT02604966
Study Brief:
Protocol Section:
NCT02604966