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 @ 2:52 AM
Ignite Modification Date:
2025-12-25 @ 2:52 AM
NCT ID:
NCT01213433
Eligibility Criteria:
Inclusion Criteria:
* Males and Females aged 6 months and above.
* Body weight of 5 Kg and above.
* RDT positive test.
* Fever (axillary temperature at ≥ 37.5°C) or history of fever in the previous 24 hours.
* Signed (or thumb-printed whenever patients are illiterate) informed consent.
* Patients' willingness and ability to comply with the study protocol for the duration of the study.
Exclusion Criteria:
* Participation in any other investigational drug study (antimalarial or others) during the previous 30 days.
* Known hypersensitivity to the study drugs.
* Severe malaria.
* Danger signs: not able to drink or breast-feed, vomiting (\> twice in 24hours), recent history of convulsions (\>1 in 24h), unconscious state, unable to sit or stand.
* Known intercurrent illness or any condition (cardiac, renal, hepatic diseases) which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.
* Severe malnutrition (defined as weight for height \<70% of the median NCHS/WHO reference).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Study:
NCT01213433
Study Brief:
Protocol Section:
NCT01213433