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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT00808951
Eligibility Criteria:
Inclusion Criteria:
* Age 6 - 59 months
* Weight \> 5 kg
* Mono-infection with P. falciparum
* Parasitemia of 4,000-200,000 asexual parasites per µl
* Fever: \> 37.5 °C or history of fever in the preceding 24 hours
* Haemoglobin \> 5.0 g/dl
* Signed informed consent by the parents or guardians
* Parents' or guardians' willingness and ability to comply with the study protocol for the duration of the trial.
Exclusion Criteria:
* Participation in any other clinical trial during the previous 30 days
* Known hypersensitivity to the study drugs
* Severe and/or complicated malaria (cases will be referred to Bobo-Dioulasso University hospital for treatment)
* 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 which would place the subject at undue risk or interfere with the results of the study.
* Severe malnutrition (weight for height \<70% of the median NCHS/WHO reference)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
15 Years
Study:
NCT00808951
Study Brief:
Protocol Section:
NCT00808951