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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT00374205
Eligibility Criteria:
Inclusion Criteria:
* Male and female outpatients aged 6 months to 59 months
* Absence of severe malnutrition
* A slide-confirmed P. falciparum asexual parasitaemia between 2,000/µl and 200,000/µl
* A measured axillary temperature ≥ 37.5 °C or rectal/tympanic temperature ≥ 38.0 °C
* Absence of general danger signs (unable to drink; repeated vomiting; recent history of convulsions; lethargic or unconscious state; unable to stand up or to sit)
* Ability to tolerate oral therapy
* Permanent residence in study area
* Informed consent by the legal representative of the subject, if possible, the parents
Exclusion Criteria:
* Adequate anti-malarial treatment within the previous 7 days
* Antibiotic treatment for a current infection
* Previous participation in a clinical trial
* Haemoglobin \< 5 g/dl
* Leucocyte count: \> 15000/µl
* Mixed plasmodial infection
* Severe malaria as defined by WHO recommendations
* Any other severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection) or concomitant disease masking assessment of response
* History of allergy or intolerance against trial medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
59 Months
Study:
NCT00374205
Study Brief:
Protocol Section:
NCT00374205