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 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
NCT00146718
Eligibility Criteria:
Inclusion criteria:
* Children 6-59 months of age
* Recorded temperature between 37.5oC and 39.5 oC
* Signs/symptoms of acute uncomplicated P. falciparum malaria.
* Positive microscopy for mono-infection with P falciparum malaria
* Asexual blood stage parasitaemia in the range 1,000 to 100,000 asexual parasites per ul
* Consent from parent or guardian of a child.
* No other apparent cause for the child's illness.
Exclusion criteria:
* Presence of signs of severe complicated falciparum malaria.
* Cerebral malaria (unrousable coma)
* Vomiting \> twice within preceding 24 hours
* More than one convulsion within preceding 24 hours
* Inability to drink or breast-feed, or to take oral medication
* Haemoglobin less than 5g/dl or a hematocrit of less than 15%.
* Documented evidence of adequate treatment with drugs expected to be effective in the preceding 72 hours
* Presence of underlying diseases (cardiac, renal, hepatic,malnutrition, gastrointestinal)
* History of allergy to study drug
* Inability to attend for the stipulated follow-up visits,
* Difficulty in accessing the health facility, or any situation or condition which may compromise the patients ability to comply with the trial procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
59 Months
Study:
NCT00146718
Study Brief:
Protocol Section:
NCT00146718