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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT00338520
Eligibility Criteria:
Inclusion Criteria:
Uncomplicated malaria (UM) Inclusion Criteria:
* Age between 6 months and 6 years, male and female.
* P. falciparum parasitemia (greater than or equal to 10,000 trophozoites/microliter).
* Clinical syndrome consistent with malaria associated with documented fever (axillary temperature greater than or equal to 38 degrees C) or reported history of fever in the last 48 hours with no other cause present.
* No other infection identified (ie. Negative blood and/or urine cultures).
* Commenced oral quinine less than or equal to 8 hours prior to enrollment.
* Parental permission obtained from parent or legal guardian.
Cerebral Malaria (CM) Inclusion Criteria:
* Age between 6 months to 6 years, male and female.
* Coma (Blantyre Coma Score less than or equal to 2) which persists for \> 30 minutes after correction of hypoglycemia and/or seizure.
* Other causes of coma excluded by lumbar puncture.
* Any degree of P. falciparum parasitemia.
* Less than 8 hours since commencement of intravenous quinine (ideally not yet commenced or soon after).
* Parental permission obtained from parent or legal guardian.
Non-malaria CNS disease (NMC) Inclusion Criteria:
* Age between 6 months and 6 years, male and female.
* Non-malaria cause of altered consciousness/coma identified (eg. Meningitis, subarachnoid hemorrhage, trauma, metabolic, toxic, post-ictal febrile seizure).
* Parental permission obtained from parent or legal guardian.
Healthy Control (HC) Inclusion Criteria:
* Age between 6 months and 6 years, male and female.
* No febrile illness within 2 weeks of evaluation.
* No active inflammatory condition identified.
* Parental permission obtained from parent or legal guardian.
* Negative RDT (rapid diagnostic test for malaria).
Exclusion Criteria:
Uncomplicated malaria (UM) Exclusion Criteria:
* Mixed infection with P. falciparum and any other malaria species (P. malariae, P. ovale, P. vivax).
* Co-infection with any other organism identified (ie. Positive blood culture).
* On quinine or artemesinin derivatives for greater than or equal to 8 hours.
* Presence of warning signs suggesting more severe disease, including the following:
1. Unable to suckle, eat and/or drink
2. Excessive vomiting
3. Abnormal respiration/respiratory distress (use of accessory muscles of respiration, tracheal tugging, intercostal retractions)
4. Recent history of convulsions
5. Altered mental state
6. Prostration (unable to sit unaided)
Cerebral Malaria (CM) Exclusion Criteria
* Untreated severe malaria anemia (hemoglobin less than or equal to 6 gm/dl).
* Lumbar puncture not performed.
* Mixed infection with P. falciparum and any other malaria species (P. malariae, P. ovale, P. vivax).
* On quinine or artemesinin derivatives for greater than or equal to 8 hours.
Non-malaria CNS disease (NMC) Exclusion Criteria:
* Lumbar puncture not performed.
* Untreated severe anemia (hemoglobin less than or equal to 6.0 gm/dl due to any cause).
* Any degree of P. falciparum parasitemia.
Healthy Control (HC) Exclusion Criteria
* Fever (Temp \> 38.0 degrees C).
* History of sickle cell disease or sickle cell trait.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
6 Years
Study:
NCT00338520
Study Brief:
Protocol Section:
NCT00338520