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 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT01144702
Eligibility Criteria:
Inclusion Criteria:
* Be aged between 6 months and 70 years old;
* Be with mono-infection confirmed laboratorial by P.falciparum;
* Having parasite count between 250/µl and 100000/µl;
* If female, not pregnant, confirmed by specific test;
* Being feverish or report having had fever (axillary temperature \>37.5°C or 99,5°F) in last 48 hours;
* Be able to receive oral medication;
* Demonstrate interest and facility to meet the schedule of visits and monitoring for 42 days;
* Agree to participate in the study by signature (or parents) of Consent Term;
* Do not show evidence of severe malnutrition: underweight 60% of the weight-standard, below-average height for age indicating malnutrition in the past and weight-height below the average indicating dietary current deficiencies (WHO, 2006);
* Do not show danger signals to severe malaria. Note: We will be careful to include individuals who have used quinine or quinidine recently (three days before), because the risk of toxicity due to interaction with mefloquine.
Exclusion Criteria:
* Present after inclusion, danger signs/symptoms for severe malaria as recommended by the WHO;
* Present after inclusion, laboratory evidence of mixed infection with another species of Plasmodium;
* Having a diagnosis of other acute infectious disease that courses with fever, such as acute respiratory infection, common viruses of childhood diarrhea, etc;
* Having a diagnosis of chronic co morbidities or severe disease such as cirrhosis, chronic renal failure or heart failure;
* Have a history of hypersensitivity to the components of the combination ASMQ.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
70 Years
Study:
NCT01144702
Study Brief:
Protocol Section:
NCT01144702